• August 4, 2020

    Tchaikapharma High Quality Medicines retains its position as the most expensive Bulgarian company on the BSE. After the players on the stock exchange estimated the pharmaceutical company at BGN 1,027,500,000 at the end of June, at the beginning of August Tchaikapharma added more value to its market capitalization reaching BGN 1,056,250,000.

     

    Read the full article here in Bulgarian.

  • July 13, 2020

    There is a company on the Bulgarian Stock Exchange with a value of over a billion leva, according to data in the bulletin of the stock exchange operator for the second quarter. This is Tchaikapharma High Quality Medicines. By the end of June, the stock exchange players estimated the pharmaceutical company at BGN 1,027,500,000.

     

    Read the full article here in Bulgarian.

  • July 7, 2020

    Briefing at the Ministry of health

  • June 30, 2020

    Global COVID-19 prevention trial of hydroxychloroquine to resume

     

    LONDON (Reuters) – A global trial designed to test whether the anti-malaria drugs hydroxychloroquine and chloroquine can prevent infection with COVID-19 is to restart after being approved by British regulators.

     

    The Medicines and Healthcare Products Regulatory Agency (MHRA) took its decision on what is known as the COPCOV trial after hydroxychloroquine was found in another British trial to have no benefit as a treatment for patients already infected with COVID-19, the disease caused by the new coronavirus.

     

    The COPCOV study was paused pending review after the treatment trial results.

     

    It is a randomised, placebo-controlled trial that is aiming to enrol 40,000 healthcare workers and other at-risk staff around the world, and is being led by the Oxford University’s Mahidol Oxford Tropical Medicine Research Unit (MORU) in the Thai capital, Bangkok.

     

    U.S. President Donald Trump said in March hydroxychloroquine could be a game-changer and then said he was taking it himself, even after the U.S. regulator, the Food and Drug Administration (FDA), advised that its efficacy and safety were unproven.

     

    The FDA later revoked emergency use authorisation for the drugs to treat COVID-19, after trials showed they were of no benefit as treatments.

     

    But Oxford University’s Professor Nicholas White, who is co-leading the COPCOV trial, said studies of the drugs as a potential preventative medicine had not yet given a conclusive answer.

     

    “Hydroxychloroquine could still prevent infections, and this needs to be determined in a randomised controlled trial,” he said in a statement. “The question whether (it) can prevent COVID-19 or not remains as pertinent as ever.”

     

    White’s team said recruitment of British health workers would resume this week, and said plans were under way for new sites in Thailand and Southeast Asia, Africa and South America. Results are expected by the end of this year.

     

    The death toll from COVID-19 surpassed half a million people on Sunday, according to a Reuters tally, with the number of cases reported globally now more than 10 million.

     

     

    Source: Reuters

     

    More information: Vimeo

  • June 19, 2020

    MoriVid (hydroxychloroquine sulfate) 200 mg, 30 tablets, expected by thousands of Bulgarian patients, is now available in the pharmacies countrywide. The distributor of the medicinal product is Commercial League – Global Pharma Center.

  • June 16, 2020

    Prof. Toni Vekov – Director of the scientific board of Tchaikapharma, prof. Rasho Rashkov – Chairman of the Bulgarian Rheumatology Society and Boryana Boteva – Chairman of the Rheumatology Patients Organisation took part in the broadcasting “Ask BNT” related to the matters of efficiency and safety of the treatment with Hydroxychloroquine (HCQ) for rheumatology-related diseases and as therapy for COVID-19.

     

    Prof. Toni Vekov: The product is already registered in Bulgaria, we have been assured by the National Organization of prices and re-imbursement of pharmaceutical products, that the price will be discussed on Thursday (18th of June). I hope MoriVid to be available in all pharmacies as of next week.

     

    A representative epidemiological study leaded by our research team, which included 56 countries, showed that in countries where 5 times more HCQ is used, mortality is 2 times lower.

     

    Prof. Rasho Rashkov: I work with Hydroxychloroquine for 36 years. The Chloroquine and the Hydroxychloroquine have a good effect [if the right dosage is applied] and are safe to a significant extent. The product is efficient in cases of COVID-19 infections as well.

     

    B. Boteva: The registration of the Hydroxychloroquine is Bulgaria is an immense achievement. Many thanks to the pharmaceutical company!

     

    Watch the full interview here /in Bulgarian/.

  • June 4, 2020

    (updated on 5 June, 14:30 )
    In response to numerous inquiries from doctors, journalists and especially from patients suffering from autoimmune diseases, we confirm inform that Tchaikapharma High Quality Medicines Inc. has developed, produced and registered for use in Bulgaria hydroxychloroquine sulfate in one galenic form. The regulatory approval is highly anticipated and very welcomed. So far, more than 4,000 people have been forced to seek the medicine from abroad or to stop their treatment, which dramatically worsens their quality of life and compromises their further treatment.

     
    We recall that after the stark opposition and widespred reaction of the international scientific community against the publication of May 22, 2020 with fabricated data in the otherwise authoritative medical scientific journal Lancet, yesterday, June 3, 2020, the World Health Organization resumed all clinical trials of hydroxychloroquine for treatment of COVID-19. The researchers from Harvard and authors of the Lancet article were forced to wear sackloth and ashes and retracted it against the disclosure of data fabrication. Just an hour later, a second article published in another legendary scientific forum, the New England Journal of Medicine, was retracted for the acknowledged use of inaccurate data collected in compromised ways and without probative value.

     
    MoriVid will be available in hospitals and in all pharmacies within days.

     
    MoriVid will be registered in 10 European countries by the end of the year.

     
    International Press Center

     

     

     

    Leading cardiac surgeon Prof. Vladimir Danov to the press:
    “Tchaikapharma” developed a production technology for a period so short that is worthy of a record and registered in Bulgaria Hydroxychloroquine Sulfate, which is wonderful news for more than four thousand Bulgarians, suffering from autoimmune diseases.

     
    You can read the whole interview here in Bulgarian.

  • April 30, 2020

    Tchaikapharma High Quality Medicines AD (BSE: 7TH) intends to build a third manufacturing plant in the village of Kazichene near Sofia. This became clear from documents published in the Commercial Register in connection with the forthcoming general meeting of shareholders, scheduled for June 22, 2020.

     

    The investment is scheduled to be completed by the end of 2022 and its workload will be almost achieved by 2026 in a favorable economic environment. The company plans to increase its production capacity with 500 million tablets annually in addition to the 450 million currently produced.

     

    The company has two plants – one in Varna and one in Plovdiv. Both structures operate at almost maximum capacity and produce almost 160 medicinal products.

     

    Tchaikapharma currently has long-term partnership agreements for the sale of medicines with companies from the Czech Republic, Slovakia, Germany, Kosovo and Yemen. Advanced negotiations are also underway with other EU companies. A few more long-term contracts are expected by the end of the year.

     

    Find the full article here in Bulgarian.

  • April 13, 2020

    President Trump takes hydroxychloroquine to prevent coronavirus infection even though it’s an unproven treatment

     

    Professor Toni Vekov in an interview with NOVA: Tchaikapharma R&D Team worked around the clock to develop our own dossier

     

    Within the next ten days, Tchaikapharma will produce about 5,000 packs of MoriVir (hydroxychloroquine), and in another week, at least 20,000 packs of GraVir (chloroquine). “Every Bulgarian diagnosed with COVID-19 will have the opportunity to be treated”, said Vekov, biotechnology engineer and one of Tchaikapharma’s founders.

     

    See the full interview here in Bulgarian.

  • April 8, 2020

    Within a couple of days, Tchaikapharma is about to produce the first 5,000 MoriVir (hydroxychloroquin) packs for the front-line hospitals in the battle against COVID-19, and in May, another 20,000 GraVir (chloroquine) packs for further hospital treatment. “From May onwards, we expect a regular production, but it all depends on access to substances, which is currently extremely difficult worldwide for well-known reasons”, Prof. Toni Vekov said in an interview with the Trud daily. The two medicinal products are in process of registration, and once they have been granted marketing authorization, they could be distributed to the pharmacy network and would thereby be available for patients on prescription only.

     

    You can find the full original interview here in Bulgarian.

  • March 5, 2020

    Tchaikapharma High Quality Medicines received a thank-you letter from Prof. Diana Ivanova, Ph.D., Dean of the Pharmacy Faculty at the Varna Medical University in connection with the “empathy and friendly support”, which the company traditionally attests to graduates in Pharmacy. 54 young pharmacists graduated at this year’s graduation ceremony 2019.

    The original letter is available here in Bulgarian.

     

  • January 7, 2020

    In 2019 Tchaikapharma (BSE:7TH) affirmed its leadership through successful development of scientific projects based on the advanced research on the development and integration of innovative combo medicines, some of which never used before in the global medical practice. Series of laboratory research and clinical studies are conducted in collaboration with European and American companies, namely in the fields of cardiology, endocrinology and neurology.

     

    Combination of different well-known molecules in PolyPill has a beneficial effect on patients, whose increased value is represented by cost-effectiveness and improved therapeutic outcomes and life comfort. Combination of substances provides the attractive opportunity to optimize admission of various medicaments in one dosage. Tchaikapharma is implementing a strategy of prioritizing patient care above all. Evidently holds on to the principles of corporative responsibility towards the community and constant innovative growth, thus managing to enter foreign markets with main focus on European countries.

     

    In an environment of increased pressure pension funds and minimal or negative interest rates of deposits in the majority of European countries, long-term investments in Tchaikapharma (BSE:7TH) proved themselves fruitful for numerous investors. Essentially, this trend is projected to continue through strengthening market presence outside Bulgaria.

     

    Tchaikapharma started crucial consolidation of its resources in order to expand its business model beyond our borders. So far, 10 pharmaceutical products have been registered in 7 EU countries. The initial stage of market entry seems to be highly optimistic.

     

    Taking into account the great market opportunities and bright prospects of Tchaikapharma’s modern portfolio, in 2019 started the design and construction of a third state-of-the-art manufacturing complex for tablets, capsules and sterile ampules, which will be dedicated to supply European markets. The new facility will feature robotized equipment and a next-gen AI process control panel, including a modern storage for pharmaceutical forms that are ready to set.

     

    Deeper entry in the fields of oncological drugs R&D is supported by another revolutionary project in 2020 – a projected investment in NGS (next generation sequencing) laboratory that will enable elaborate research of human gene and detection of mutation which are highly relatable to specific oncological diseases. This would allow therapy to be optimized personally for each patient, providing maximum suitability and efficacy.

     

    Therefore, the possibility of positive therapeutic response is increased many-fold, and side effects inherent to conventional methods of oncological therapy, limited. Consequently, such personalized therapeutic approach based on NGS analysis, minimizes the risk of disease relapse. The high-tech laboratory will be one of its kind in the Balkans and will provide patients form the region (East of Munich) health technologies solely available in some countries in Western Europe and the USA.

     

    Today, Tchaikapharma is one of the largest companies on the Bulgarian Stock Exchange, with market cap of 895 million BGN as of the end of 2019 – trustworthy of its numerous investors and immense prospects.

     

    The original article is available here in Bulgarian.

  • December 5, 2019

    The newest addition to Tchaikapharma High Quality Medicines Inc. prescription drugs (Rx) product list are the following:

     

    - Zornichka (chlorthalidone) – for the treatment of arterial hypertension, essential or renovascular, or isolated systolic hypertension;

     

    - PlaquEx Combi (clopidogrel/acetylsalicylic acid) – for the secondary prevention of acute cardiovascular events;

     

    - Methylprednisolone -Tchaikapharma (methylprednisolone) – for the treatment of endocrine, rheumatic, collagenosis and immune-complex, skin, eye, gastrointestinal, respiratory,  hematological, oncology and edema diseases, as well as allergic conditions.

  • November 14, 2019

    Numerous spectators attended the traditional restoration of the Battle of Slivnitsa. Many volunteers were involved in the recreation of the events of the Serbo-Bulgarian War of 1885.

     

    slivnitsa-2019-1

     

    This year again, Tchaikapharma’s team took part in commemoration, as they traditionally participate in the recreation of historical events.

     

    Оn November 7, 2005, the company built and offered to the citizens a monument in memory of the killed Bulgarian officers, NCOs and soldiers on the occasion of the 120th anniversary of the victory in Slivnitsa of the Bulgarian army in the Serbian-Bulgarian war. The monument was inaugurated in the presence of the Vice President of the Republic of Bulgaria, Gen. Angel Marin, war veterans, representatives of military organizations and numerous citizens.

     

    slivnitsa-2019-2

     

    The recreation organizer is the national “Tradition” society – a voluntary, nongovernmental patriotic organization aimed at promoting and preserving patriotic traditions of military symbols and rituals, national values, weapons as a tribal memory, organizing and participating in recreating and events and battles of Bulgarian history.

     

    slivnitsa-2019-3

     

    After the historical recreation, the participants took a picture in front of the monument built by Tchaikapharma.

  • October 23, 2019

    Bulgaria’s Young Talents in The Field of Synthetic Biology Expressed Their Gratitude for The Support Provided

    mladi-talanti-biologia

    Tchaikapharma High Quality Medicines Ltd. supports Bulgaria’s Team of Synthetic Biology young specialists at their participation in the biggest bio engineering contest on the Planet – iGEM. The competition takes place in Boston, USA each year and accommodates more than 350 university teams from around the world. The Bulgarian team consists of future scientists and doctors from the Sofia University “Saint Kliment Ohridski”.

    Besides being a platform for young scientist development, iGEM is also looking to obtain solutions to socially viable challenges. The Bulgarian project is dedicated to a global issue – resistance of pathogenic microbes to antibiotics. Antimicrobial resistance is one of the main threats to human and animal health. It causes more than 33 000 deaths in the European Union each year and financial losses are over 1.5 billion Euro.

    The negative tendency for constant growth of the number of infections such as tuberculosis, pneumonia and others, which are caused by pathogenic microbes that are resistant to the currently applied medicines, define the antimicrobial resistance as a global issue with a significant relevance. According to the World Health Association and the European Commission, if no new treatments are found up to 2050, 10 million people will die every year due to infections, caused by multi-resistant bacteria.

    The team will travel at the end of the month and is currently preparing for the competition at the Sofia Tech Park labs.

     

  • Tchaikapharma High Quality Medicines ranks among the leaders in the Prescription Drugs (Rx) market for the past 12 months (as of June 2019).

     

    The ranking “Top 10 Corporations in the market for prescription products” of the world’s leading analytics company IQVIA  takes into account sales at end-customer prices, with Tchaikapharma increasing its market share is now ranked second by number of packages sold.

     

    The top ten Rx companies in Bulgaria hold 45% of the total market for prescription drugs.

  • September 18, 2018

    By the end of 2018, Tchaikapharma expects to be issued with Marketing Authorizations for three new prescription drugs, which will enrich the portfolio and the well-developed therapeutic baskets of the company with the following medications and indications:

     

    Chlorthidon (chlorthalidone) – for the treatment of arterial hypertension, essential or renovascular, or isolated systolic hypertension.

     

    PlaquEx Combi (clopidogrel/acetylsalicylic acid) – for the secondary prevention of acute cardiovascular events.

     

    Methylprednisolone-Tchaikapharma (methylprednisolone) – for the treatment of endocrine, rheumatic, collagenosis and immune-complex, skin, eye, gastrointestinal, respiratory,  hematological, oncology and edema diseases, as well as allergic conditions.

     

    Tchaikapharma International Press Center

  • September 12, 2018

    Tchaikapharma completed the bioequivalence clinical trials of 4 new dual-component pharmaceutical products for the treatment of arterial hypertension and other cardiovascular diseases – with sucsess. The new drug fixed-dosage combinations with angiotensin receptor blockers and thiazide or thiazide-similar diuretics represent innovative solutions for an advanced medical care.

     

    The researched and other already registered new combined pharmaceutical products are innovative scientific solutions developed by Tchaikapharma and are extensively prescribed by doctors and are met with a wide satisfaction by patients – in Bulgaria and a number of pharmaceutical markets in the EU.

     

    On 20 August 2018, the Food and Drug Administration of the USA made a proposal for simplification of the registration procedure for exactly this kind of pharmaceutical combinations and the Administration described them as “complex” and accepted their innovative combined effect and high efficacy, which cannot be found in the already known mono-component generic medications.

     

    Tchaikapharma’s laboratories are completing the development, and more importantly, are about to finish – within the next 18 months – the clinical trials of the three-component pharmaceutical products for the treatment of cardiovascular disease and diabetes.

     

    Cardiovascular diseases and diabetes are the chronicle conditions with the highest morbidity and longest duration in the EU countries, which lead to acute complications such as myocardial infarction, stroke and other severe life-threatening events.

     

    Tchaikapharma International Press Center

  • May 3, 2018

    Pizona Combi contains pioglitazone and metformin that controls blood sugar levels.
    It helps the body to utilize better produced by body insulin when metformin alone is insufficient.
    The medicinal product is subject to medical prescription.
    For more details, please check section Products
    ATC код: A10B 02

  • March 29, 2018

    The 33rd National Meeting of the Association of Medical Students in Bulgaria was held in Pleven from 16 to 18 March with the support of Tchaikapharma.

     

    A specially designed booth will welcome the participants in the eighth scientific conference of the Bulgarian Cardiac and Vascular Association under the auspices of the Rector of the Medical University of Pleven. The conference entitled “Contemporary Accents in Cardiac and Vascular Pathology” starts tomorrow, 30 March 2018, and will last for two days.

     
  • March 14, 2018

    Tchaikapharma has won award in the category of solution providers during the Pharm Connect congress which is the most notable meeting of leading pharmaceutical and biotechnology companies for Central Eastern Europe and CIS region.

    The excellence award was given for the successful incorporation of the latest running and implementation system. This has been a joint project of Tchaikapharma and Softgroup ,the latter creating the software and providing  the technical equipment for the system.

    The purpose of all that was to build a running system that meets all the requirements of some of the European directives  for falsified medicines. This leads to the fact that production capacity will be connected to the European hub for tracking every package that has been produced and sold.

    Tchaikapharma is the fastest growing pharmaceutical manufacturer operating in Bulgaria. The company is focused on making available contemporary therapeutic solutions on the local, regional and European market in accordance with GMP. Tchaikapharma has an annual manufacturing capacity of 500 million tablets and 17 million secondary packaging boxes.

    tch-award-budapest

  • April 21, 2017

    The newest addition to Tchaikapharma High Quality Medicines Inc. product list is Ivabenor 5 mg and 7,5 mg film-coated tablets. The cardiological medicinal product contains the active substance ivabradine.

    Ivabenor is indicated for the treatment of patients with chronic stable angina pectoris and chronic heart failure.

    ATC code: C01EB 17

  • April 13, 2017

    tch_vp1

    Tchaikapharma High Quality Medicines Available for All wishes you a Happy Easter!

  • March 24, 2017

    tch_sgrada

    Interview with the production manager at Tchaikapharma’s plant in Plovdiv – Vasil Pavlov.

     

    The requirements for the production of medicinal products resulting from the GMP (good manufacturing practices) enforced around the world approximate (and in many cases exceed) the requirements for operating rooms in hospitals. Medicines are produced in a rigorously monitored environment to ensure that there is absolutely no pollution, especially of the air, so that microorganisms and contamination by other drugs could not be introduced into the finished products.

    GMP fully regulates each step: from production of the substance, through mixing with excipients and tabletting, to packaging, storage, transportation. Distribution and sales in pharmacies is regulated by GDP.

    Generally the active substances are manufactured in China or India. The synthesis of these essential substances is quite energy intensive and highly polluting, so even large Western pharmaceutical companies buy them from these countries. The quality requirements for the said substances are listed in the current editions of the European Pharmacopeia, which are mandatory for the respective country.

    Any substance or excipient comes with a certificate. Nevertheless these products are re-checked in the onsite laboratory. And not only that – subject to verification is even whether the laboratory parameters of the manufacturer of the substance are identical to those that are approved for sale in the country.

    “Once the ingredients arrive from the manufacturers, they are placed in an area under quarantine until they pass all laboratory testing”, explained the production manager at Tchaikapharma’s plant in Plovdiv – Vasil Pavlov.

    The release from this area takes place only after a complete match between the results from different laboratories and the approved specifications was established.

    The laboratory equipment is state of the art, because the quality requirements for the medicinal products are steadily increasing as a result of regulatory pressure in line with the advancement of science. As the plant produces exclusively generics, to market such medicinal product, its manufacturer must have registered in the Bulgarian Drug Agency the dossier which corresponds to the entire dossier of the original drug. And it is full of laboratory and clinical test results that should be met in the generic product. Without achieving these targets, the medicinal product simply could not reach the market because the Bulgarian Drug Agency would not allow it.

    We begin the tour from the room where the barrels with substances are received. It is built as a pass box – if the door on one side of this compartment is open and a truck is being unloaded, the other door cannot be opened in order to avoid mixing of flows as from one side external persons have access to this room. Beside the other door is the so called grey area where higher purity requirements are applied. The highest requirements are in the blue zone where the medicinal products are manufactured.

    Moreover, the people can move in one direction only – they cannot exit the sterile zone and then re-enter without preparing again for this – they should dress in clothes that tightly cover the entire body, wear mouth mask and head cover cap, shoe covers or special work shoes. On the hands they should wear gloves. And nonetheless they are washed separately with a solution for disinfection.

    One cannot move randomly from one room to another, because frequently a certain product is produced in one room and another in the other.

    The most important for the production premises where medicines are manufactured is the control of the number of solid particles in the air, since the microorganisms are carried precisely by the solid particles. It is scientifically proven that most microbes are carried by particles with a size between 0.5 and 5 microns. Therefore, ventilation and air conditioning system should not allow infiltration of precisely such particles. This is achieved by circulating and filtering the air. Automatically a temperature of 22 degrees, 45% humidity and a higher air pressure than in the outside area are maintained, which helps blow out the solids through special vents.

    Before entering the production premises the personnel passes through another pass box. There the people change clothes. “This is being done because human beings are the biggest polluters that enter the premises”, says Vasil Pavlov.

    Before entering the working environment, everyone can see the parameters of the room which is to be entered. They are shown on special screens on every door. They provide information on temperature, pressure and humidity. If the parameters are out of norm, the screen indicates that the person should not enter.

    After the pass box there are premises where all the technological processes take place. There are a lot of glass partitions and windows that allows to see what is going on in every room, without having to enter it.

    Currently tablet forms are manufactured there. Night shift is avoided even when very busy, because at night more mistakes are made. When there is a lot of work, they work overtime, but during the day.

    In the first room is the formulation department. In large machines formulations for various drugs are entered and a software ensures that operators do not make mistakes in the amount or type of material. The addition of materials is performed in strict sequence. A tightly closed container that contains all the ingredients of the medicinal product exits this premise. The mixture is moistened by applying a particular technology with the addition of solutions. Thus granules with different sizes for different medicines are obtained and the most common dimensions are in microns.

    In a separate room the so called dry mixing is carried out in order to obtain a homogeneous mixture. The “Mixer” is quite special – it rotates at different speeds for different times and, most notably, spins the mixture in several directions. Thus, it is certain that each tablet will have all the ingredients.

    Throughout the technological process for the manufacture of medicines who did what is recorded, who prepared the container, who washed it afterwards, who prepared the tableting press, who then washed the machine parts, etc. There is also a laboratory for intermediate control where the solution and mixtures are tested to check whether all the ingredients are there, to control the moisture, the weighs of each volume of the mixture.

    The friability of the tablets is tested – the medicine is rotated and the pressed to see how much of it will be lost.

    The works are performed with high precision using analytical scales that measure weight in grams with several digits after the decimal point. Any equipment that enters the separate zones is previously washed and sampled to check whether it is cleaned well.

    For washing purified water, alcohol, detergents and disinfectants are used. After this procedure samples are taken from the containers to ensure that every time they were washed in the same way.

    We come to the most important machines – those that produce the tablets. The operator has no access to the mixture during the production process – the mixture moves with the help of vacuum and enters the presses that make tablets. Each tableting press can produce up to 150,000 – 200,000 tablets per hour.

    Packaging in blisters and cartons is done in a room on another floor and half of the packing line, where the tablets are brought before being closed in blisters, is in a controlled environment.

    Some of the tablets are film-coated – this is an additional guarantee that the active substances will not disintegrate. Only medicines with unstable substances are film-coated. Some tablets are pelleted because the taste of the drugs is usually not very pleasant. Very soon the plant will have an installation for the manufacture of capsules.

    The walls in manufacturing facilities are cladded with special pharmaceutical panels. They are perfectly smooth, do not retain any particle, and ensure that any dirt will be washed of with detergent only. The silicone which seals joints between the panels is special also and ensures that the preparations will not damage it over time. It is produced for pharmaceutical companies and operating rooms.

    Currently at Tchaikapharma 80 % of the distributed medicinal products are in-house manufacture, and 20 % are imported as finished medicinal products or are only packaged at Tchaikapharma.

     

    [The original article was published in the specialized business edition “.bg”, March – May 2017; author Georgi Vasilev. The text should be perceived as an attempt by the author to present in popular intelligible language the high-tech processes which were presented to him by Tchaikapharma’s team during the plant tour in Plovdiv.]

  • March 9, 2017

    Bortezomib-Tchaikapharma 3.5 mg powder for solution for injection is Tchaikapharma High Quality Medicines’ newest medicinal product which obtained a Marketing Authorisation by the Bulgarian Drug Agency in the beginning of February 2017. The active substance contained is Bortezomib (as a mannitol boronic ester).

    The medicinal product is subject to medical prescription.

    ATC code: L01XX 32

  • February 20, 2017

    Tchaikapharma High Quality Medicines Inc. received another Marketing Authorization by the Bulgarian Drug Agency with which the company updated its list of injectable products. The new oncological drug product is called Pemetrexed-Tchaikapharma 500 mg powder for concentrate for solution for infusion and is used in the treatment of malignant pleural mesothelioma and non-small cell lung cancer.

    Еаch phial contains the active substance Pemetrexed (Pemetrexed disodium hemipentahydrate) and is subject to medical prescription.

    ATC code: L01BA04

  • February 9, 2017

    Bortezomib-Tchaikapharma 3.5 mg powder for solution for injection is Tchaikapharma High Quality Medicines’ newest medicinal product which obtained a Marketing Authorisation by the Bulgarian Drug Agency in the beginning of February 2017. The active substance contained is Bortezomib (as a mannitol boronic ester).

    The medicinal product is subject to medical prescription.

    ATC code: L01XX 32

  • February 2, 2017

    Lidocaine-Tchaikapharma 10 mg and 20 mg solution for injection is Tchaikapharma’s newest product which has obtained a Marketing Authorization issued by the Bulgarian Drug Agency.

    Therapeutic indications:

    • For local anesthesia in surgery, dentistry, urology, cardiology, ophthalmology, otorhinolaryngology and other invasive instrumental investigations.
    • For the treatment of ventricular arrhythmias, including after myocardial infarction and cardiac surgery interventions.

     

    ATC code: C01BB 01, N01BB 02

  • December 23, 2016

    tch_kartichka_eng

  • November 23, 2016

    The renowned business ranking “300 Business Leaders in Bulgaria” for one more year honoured Tchaikapharma High Quality Medicines Inc. as one of the most profitable and influential companies in Bulgaria.

    The ranking’s fifth edition prepared by analysts from ICAP Group brings together the most successful companies in the country for the past year 2015, based on the criterion “Earnings before interest, taxes, depreciation and amortization (EBITDA)”.

    This year Tchaikapharma marked alike a growth on the paramount indicators ‘profit’ (13%) and ‘equity’ (15%). In 2015, EBITDA-profit of the company rose by nearly 11% over the previous year.

    These positive trends determine the high market capitalization of the company amounting to approximately 372.5 million leva (as of 21/11/2016).

  • November 15, 2016

    The newest product of Tchaikapharma High Quality Medicines Inc., which BDA gave a marketing authorisation for, is Cilapenem 500 mg/500 mg powder for infusion solution.

    Each phial contains the following active substances: 530 mg imipenem monohydrate, which is equivalent to 500 mg imipenem anhydrоus, and 532 mg cilastatin sodium, equivalent to 500 mg cilastatin.
    The drug is indicated for the treatment of infections in adults and over 1 year-old children:

    – Complicated intra-abdominal infections;

    – Severe types of pneumonia, including nosocomial pneumonia and ventilator- associated pneumonia;
    – Infections during and after birth;
    – Complicated urinary tract infections;
    – Complicated skin and soft tissue infections

    Tsilapenem is also suitable for the treatment of patients with:
    – Neutropenia and fever, suspected to be due to bacterial infection;
    – Bacteraemia occurring in connection with or presumably associated with any of the above infections.

    The medicinal product is subject to medical prescription.
    ATC code: J01DH 51

  • November 7, 2016

    The newest medicinal product placed on the market after having received a marketing authorization from the Bulgarian Drug Agency by the Ministry of Health is the infusion solution Linezolid-Tchaikapharma 2 mg/ml.
    Its active substance is linezolid, and a packaging contents 300 ml x 5 pcs. or 10 pcs.
    This medicinal product is used in cases of hospital- or community-acquired pneumonias, where they are known or suspected to be caused by sensitive Gram-positive bacteria.
    Linezolid-Tchaikapharma is subject to medical prescription.

    ATC code: J01XX 08

  • September 2, 2016

    On the Bulgarian pharmaceutical market the latest addition to constantly growing product list of Tchaikapharma High Quality Medicines Inc.  for the treatment of cardiovascular diseases is offered from today.

    The product Cardesart-Co x 30 tablets, an international non-proprietary name Candesartan/Hydrochlorothiazide, in concentrations of active ingredients 8 mg/12.5 mg and 16 mg/12,5 mg registered under the decentralized procedure was included in the list of NHIF under the following codes: CG285 and CG284.

    Candesartan belongs to a group of medicines called angiotensin II-receptor antagonists and Hydrochlorothiazide belongs to a group of diuretics. Cardesart-Co is indicated for the treatment of essential hypertension in adults whose blood pressure is not optimally controlled with Candesartan or Hydrochlorothiazide monotherapy.

    CardesartCo 3D.cdr

  • July 19, 2016

    After successfully completing the third for the company Decentralised Procedure (DCP) Tchaikapharma High Quality Medicines Inc. received Marketing Authorisation for the medicinal product Tamayra 5 mg/5 mg hard capsules and Tamayra 10 mg/5 mg hard capsules, for which Bulgaria is the country of reference

    This is the first international procedure for Marketing Authorisation of medicinal products for which our country is the reference country. Concerned are six European countries – the Czech Republic, Romania, Portugal, Slovakia, Greece and Austria.

    Tamayra belongs to a group of modern combined drug therapies for cardiovascular diseases based on ACE inhibitors and calcium channel blockers.

    ATC code: C09BB 07

  • July 14, 2016

    Tchaikapharma High Quality Medicines Inc. was granted Marketing Authorisations for the medicinal products Ibodria 6 mg/6 ml concentrate for solution for infusion and Ibodria 3 mg/3 ml solution for injection in pre-filled syringe. The active substance contained is Ibandronic acid (as ibandronate sodium monohydrate).

    The medicinal product is indicated for the treatment of osteoporosis in postmenopausal women with increased risk of fracture. A reduction in the risk of vertebral fractures is proven.
    Ibodria is subject to medical prescription.

    ATC code: M05BA 06

  • June 30, 2016

    The Bulgarian Pharmaceutical Union awarded Tchaikapharma High Quality Medicines Inc. for cardiological medicinal product Amariton in the category “Medicinal Product Subject to Medicinal Prescription – made in Bulgaria” for 2016. The Awards ceremony took place at the Tenth anniversary edition of the Bulgarian Pharmaceutical Days, held from the 24th to 26th of June 2016 at the National Palace of Culture, Sofia.

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  • June 27, 2016

    Tchaikapharma High Quality Medicines Inc. was granted Marketing Authorisations for the medicinal products Atorva 40 mg and 80 mg film-coated tablets. Each tablet contains the active substance atorvastatin as atorvastatin calcium.

    Atorva is indicated:

    – as an adjunct to diet to reduce elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in adults, adolescents and children over the age of 10 with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) and combined (mixed) hyperlipidemia (corresponding to Fredrickson’s classification type IIa and IIb), when response to diet and other non-pharmacological methods is insufficient;

    – for lowering total cholesterol and LDL-C in adult patients with homozygous familial hypercholesterolemia as an adjunct to other methods of decreasing the level of lipids (e.g. LDL Apheresis) or in cases where these methods are not available;

    – for prevention of cardiovascular events in adult patients at high risk for a first cardiovascular event as an adjunct to correction of other risk factors.

    Atorva is subject to medical prescription.

    ATC code: C10AA 05

  • May 13, 2016

    On 10/05/2016, the BDA successfully completed within the specified period the first decentralised procedure (DCP) for marketing authorisation of medicinal products for which Bulgaria is the Reference Member State (RMS).
    A team of experts from the BDA assessed the documentation, in connection with the Marketing Authorisation of medicinal products Tamayra 5 mg/5 mg hard capsules and Tamayra 10 mg/5 mg hard capsules, with Marketing Authorisation Holder Tchaikapharma High Quality Medicines Inc., Bulgaria. The procedure was adopted by the other six Concerned Member States (CMSs) as well.

  • April 7, 2016

    Dear Colleagues,

     

    Happy Holidays!

     

    Your everyday efforts to improve people’s health and save people’s lives are and have always been worthy of respect!
    All impediments we face with combined efforts every day to ensure that every Bulgarian has the right of access to the most up-to-date treatment and
    quality life make us not only stronger, more united, better professionals, but are also a point of pride!
    You are the pride of Bulgarian healthcare!
    With best wishes for health, professional success and personal happiness!

  • January 11, 2016

    This year again, employees of Commercial League assumed the role of Santa Claus and delighted the kids from Konstantsa Lyapcheva orphanage in the town of Dolna Banya.
    More than 20 children were asked to send letters with their Christmas wishes, and the team of Commercial League tried to make them true. Besides the dream gift, each child also received a personal message on the occasion, and to the delight of everyone a real table football table was fitted in the common room of the orphanage.
    The whole day was filled with wonderful emotions, games and many shared smiles!

  • November 6, 2015

    The National Health Service in the UK discontinues the coverage of 25 cancer drugs
    Twenty five drugs that each year give a last chance to patients with cancer – including breast, prostate and colon cancer will not be funded by the National Health Service in the UK (NHS), which plans to optimize the costs for 2015, and to restructure the budget in an optimal way.

    Non-governmental organizations accuse the health authorities in taking “a dramatic step backwards” and destroying the lifeline, which extends the lives of thousands of cancer patients. Annually more than 3000 patients with colon cancer, as well as 1 700 patients with breast cancer will be affected by the decision. Medications that no longer receive funding in some cases, have been increased the life expectancy from eight months to two and a half years, according to the statistics.

    In 2011 the center-right coalition in the UK set up a special fund for cancer drugs, following the publicly requested by the conservatives commitment not to deny more treatments because of financial considerations. Although the Fund’s budget was increased from 200 to 280 million pounds, the demand proved to be such that by the end of the financial 2015 it is expected to have spent nearly 380 million.

    At the beginning of the year the NHS announced it would increase its annual budget to 340 mln., but even with this increase the fund cannot afford to continue paying for all cancer treatments, which have been financed until now. The patients, who have  already received funding approval  up to April, will continue receiving their medicines from the NHS.

    The Chair of the Fund said that “difficult decisions” had to be taken in order to give priority to the medicines that show best values, and that such a step has been obligatory. From the 84 treatments, examined in the analysis of the fund, 59 continued to be funded after March this year, while 25 were “written off”. Five treatments for colon cancer, four for leukemia, three for breast cancer, three for lymphoma, three for sarcoma, as well as drugs used to treat prostate, ovary, lung, pancreas and kidneys cancer  are among those which are no longer financed.

    There are three new drugs that will continue to be funded after the analysis – Panitumumab – for treating colon cancer; Ibrutinib – for treating mantle cell lymphoma, non-Hodgkin’s lymphoma type; and Ibrutinib – for treating chronic lymphocytic leukemia.

     

    Professor Peter Clark, Chair of the Fund, said: ” We have been through a robust, evidence-based process to ensure the drugs available offer the best clinical benefit, getting the most for patients from every pound.” “These are difficult decisions, but if we don’t prioritise the drugs that offer the best value, many people could miss out on promising, more effective treatments that are in the pipeline.” The decisions were taken as a result of the analysis of experts on the national level – including oncologists, pharmacists and representatives of patients who independently of each other reviewed the drugs available so far in the Fund, as well as the new applications. Their evaluation included clinical benefit, survival and quality of life, safety and toxicity of treatment, the level of unmet need and the average cost per patient.

     

    Lord Darzi, former Labor health minister, said that the NHS should stop the unnecessary treatment of dying patients in order to help financing and this way – the increase in the cost of new cancer drugs. He told The Times, that the reduction of unnecessary tests and treatments with little chance of success will free up money for expensive modern and better medicines that the health service is struggling to provide for patients.

  • October 20, 2015

    Tchaikapharma High Quality Medicines Inc. was distinguished among the most profitable and influential companies in Bulgaria for the 2014 business rating “300 Business leaders in Bulgaria”.

    In this year’s forth edition the business analysts from the ICAP Group rated the most successful companies in the country accordingto the Earnings Before Interest, Taxes, Depreciation, and Amortization (EBITDA) criterion.

    For a consecutive year Tchaikapharma marked a growth in profit and equity. In 2014 the Company’s profit grew by nearly 9 % over previous year, the average value of this indicator of the companies in the rating is only 4.7%.

    In its sector “Production of medicines and medicinal products” Tchaikapharma is ranked first based of the criterion “profitability of EBITDA”, i.e. shows the best ratio between profit and the amount of sales revenue. The profitability of Tchaikapharma (40.19 %) significantly exceeded the indicators of other companies in the sector – Sopharma (19.94 %), Balkanpharma – Troyan (19.02 %), Biovet (14.59 %) and Balkanpharma Dupnitsa (10.51 %).
    These are the main reasons for the high market capitalization of the company amounting to nearly 255 million BGN (as of 20.10.2015).

  • October 6, 2015

    The participants in the National Round Table on Reforms and Healthcare without Restrictions insist that the government restores the principle “the funding follows the patient”

    “We do not accept and will not accept in the future the activities of the medical institutions to limit and thereby to put bounds on the rights of patients to have access to timely and quality treatment.” So begins the declaration which has been signed by the Center for the Protection of the Rights in Healthcare, the Federation Bulgarian Patients’ Forum and the Bulgarian Association for Patient Rights, the National Association of Private Hospitals, the Association of Municipal Hospitals, and the directors of more than 30 hospitals. The participants were against the norms that lead to the administrative closing down of hospitals, the forced mergers, and the imposing of administrative limitations on the construction of new hospitals. According to them, the success or failure of a hospital should depend entirely on whether the patients are satisfied or not by the treatment provided.

    “We insist that the government restores the principle “the funding follows the patient ” and creates the necessary rules for the effective and objective control by the institutions, as well as by the consumers of medical services, over the quality of medical activity,” states the declaration.

    According to a reference of the Health Fund,  provided to the Medical Association, from March to July the hospitals have exceeded their limits for BGN 31.8 million, which at the end of the year is expected to reach BGN 60-65 million. In a letter to the NHIF the chairman of the BMA Dr. Ventsislav Grozev points out that the healthcare providers are becoming “unpaid donors of the healthcare system.” The Professional Association recalls the legal precedents so far which show that ultimately the NHIF will have to pay the hospitals for the performed activities together with the accrued interest.

    Stoycho Katsarov from the Center for the Protection of the Rights in Healthcare stated that all agree that currently the system is not good and needs to change, but he is skeptical whether the reforms undertaken would lead to the desired effect. “The healthcare system would be at its best when it is viewed as a market that offers business services, and not as an administration,”  he noted.

    The National Association of Private Hospitals commented that the limitations achieve the opposite of what the government claims, namely that the reform works in favor of a higher quality and comprehensive treatment. “The patient goes to the hospital, where he is told he cannot be admitted because of the restrictions. He returnes home and waites to be admitted by this particular doctor at this hospital which he has chosen while his illness is getting worse and his treatment is becoming more expensive. Doctors are beginning to lose confidence in the system and motivation. What this reform achieves is a more expensive treatment, not better quality. ”

    Patients’ representatives stressed that the populist statements of politicians that the restrictive policies are in the interest of patients, are not true. “When you undertake reforms in healthcare, it is useful to hear the voice of both – the patient and the professional organizations.”

    “If someone steals through clinical pathways, this should be controlled and determined by the NHIF,” said the chairman of the Association for the Protection of Patients and noted that the vicious circle of generating activity that exceeds the limit is due to the planned budget deficit of the NHIF in the recent years .

    “We need an urgent discussion on the subject matter of the healthcare budget for 2016,” said the representative of the Supervisory Board of the NHIF Grigor Dimitrov. As an employer,  the representative of the Confederation of Employers and Industrialists in Bulgaria in the Supervisory Board was adamant that the limitations are not the way to manage any kind of activity.

    The Roundtable participants agreed on the idea that the state should take care to increase the collection of the health insurance contributions, as well as the payment of the full amount. They insisted on increasing the percentage of the GDP for healthcare, which is separated from the budget. The guild accepts the stated intention of the government to provide comprehensive treatment in full, observes that it is available not only through the impoverishment of the structures, but also through organizational and financial mechanisms.

  • The specialized hospitals of the Bulgarian Cardiac Institute in Varna, Veliko Tarnovo, Shumen and Yambol mark the World Heart Day with an appeal for prevention and free consultations

    Every year on the 29th of September  the world celebrates the International Heart Day. In connection with this the experts reminded us that according to the “black statistics” every third death in our country is a result of cardiovascular disease, although 80% of the cardiac problems are preventable if detected on time.

    “Atherosclerosis and cardiovascular disease are considered to be the largest non-infectious epidemic diseases of our time, in a word – they are the biggest killer of the 21st century,” said the national consultant in Cardiology Assoc. Prof. Ivo Petrov, MD.

    “The high level of lipids in the blood is a major risk factor in the early development of cardiovascular disease. The lipids that circulate in our blood come mainly from two sources. One depends on how a person eats and the second, which is even more dangerous, is genetically determined – these are the lipids that our own organism has synthesized. A lot of people have this kind of family history, but it may be less or more risky, depending on the case. In such people the developing of cardiovascular diseases is not potential, it is the rule.

    In order to determine whether we are genetically endangered or not it suffices that we know the history of the disease and the cause of the fatal end in our parents or their parents. We, cardiologists, constantly insist on mass screening which should follow simple clinical criteria and laboratory tests. The verification through the lipid profile is widely available throughout the country. But any changes in the electrocardiogram and the echocardiogram should be monitored as well, which, however, are carried out during the second stage. And mainly in people who have cases of early signs of atherosclerosis in their family – either a stroke or myocardial infarction. This is the target group of the Bulgarians who definitely have to be tested, in order to determine if they have a hereditary predisposition to these diseases or not. ”

    This year the hospitals of the Bulgarian Cardiac Institute – the Specialized Hospital for Active Treatment in Cardiology in Varna, the Specialized Hospital for Active Treatment in Cardiology in Veliko Turnovo, the Specialized Hospital for Active Treatment in Cardiology in Yambol, and the Specialized Hospital for Active Treatment in Cardiology in Madara – Shumen are joining together in the celebration of the World Heart Day by offering free examinations, taking blood pressure and providing individual consultations.

  • October 2, 2015

    For the first time clinical trials will be conducted to check if a drug prolonged life, said magazine  Sciences et Avenir. The medicine in question is metformin, which is often administered to patients affected by diabetes type 2. In 2008, the study of Russian scientists showed that it prolonged the lives of mice, probably by restricting the calorie intake and controlling the level of glucose. The published in 2014 results from the statistical survey conducted by scientists from the University of Cardiff, UK, included 180 000 people and showed that the treated with metformin diabetics had higher life expectancy than non-diabetics.

    This is why, the expert Nir Barzilai at the Albert Einstein College of Medicine in New York launched the TAME / Targeting Aging with Metformin /project. It will monitor the health of 3 000 non-diabetics aged over 70, some of which will be taking metformin for five years, while the other participants will be included in the control group.

    Other anti-aging drug – rapamycin, is also being tested. It suppresses the immune response and is often prescribed during transplants. It has been tested on mice and prolongs their lives. Currently, the scientists from the University of Washington in Seattle tested the drug on dogs. Their hopes are that rapamycin will extend the life of the four-legged animal from 2 to 5 years.

    Tchaikapharma High Quality Medicines Inc. offers on the Bulgarian market  Metformin-Tchaikapharma (metformine), indicated for the treatment of type 2 diabetes mellitus.

  • According to Minister Moskov, when one has a facility in the big city where people have assets, one has to take responsibility for the system as well. According to the guild, the solution is to permit subsidiaries

    Administratively forcible is the method imposed by the state that out of the 4 pharmacies, which an owner is entitled to have, one necessarily has to be located in a small village, the second one – to work round the clock and the other two – whatever the owner considers.

    This is what was stated by Nikolay Kostov, chairman of the Association of Pharmacies Owners, in connection with the forthcoming reforms in the Drug Law by the Health Minister Dr. Petar Moskov, which would be the next one to be “repaired”. Kostov predicted that if the idea was implemented, the owners would go around it. For example, a natural or legal person would open up to 2 pharmacies in the cities wherever they decide, and this way the requirement for the other two would be avoided.

    The Minister launched his proposal in February this year and then he said:” when one opens a pharmacy in the big city where people have assets, and it is effective, one has to take responsibility for the system, even if this is not a market method”.”Even during post-socialist times there was no such regulation! The opening of pharmacies is encouraged in small towns everywhere in the EU, but only where this is possible. In some places it is a lost cause,” said Kostov.

    According to research, in order for a pharmacy to exist in the EU, there should be at least 1200 inhabitants, while in some places a pharmacy serves 15 000. Another determining factor is overcharge. The more it is “suppressed”, the more patients are needed in order for the facility to not go bankrupt. “In our case, although higher overcharge is permitted, it is usually 10-13 to 14%. Of course, if it is 30%, then the pharmacy can function even in a village with 800 people,” said Kostov. He added that people from smaller places have a different income and consumption than in cities. And if the village has no doctor, it is absurd to open a pharmacy, because no one can prescribe medication. And if the patient goes to a big city to see a doctor, it is logical he would to buy his drugs there as well.

    Kostov recalled that years ago the state and the municipalities were allowed to open pharmacies, but they all were privatized, as they had debts. “So the state abdicated from this type of activity, and now wants to move it over to us”, he added. While the idea may seem social, it was “wild populism” that protects only the interests of the occupational group.  According to the Association of Pharmacies Owners a solution would be to allow the pharmacies in major cities to have branches in small villages which would work 1-2 times a week for several hours, and not only with a master pharmacist, but with an assistant pharmacist as well.

  • Doctors specializing in Medicine will have a right to a contract with the NHIF was decided by the MPs yesterday, when they accepted the amendments to the Law on Medical Institutions. This way they made the promise of the Health Minister Petar Moskov, which he made to the doctors in the campaign “Young Medic”, become a fact.

    Specializing doctors currently do not have the right to work with the Fund and this is the reason why hospitals find it difficult to provide the necessary funds to ensure they have good salaries. However, this will change with the changes and clinics will want to recruit young physicians on staff. Furthermore, the MPs adopted the opportunity for emergency doctors to work more flexible shifts, and in the areas where there are no clinics, physicians are required be on duty at least 10 hours a week.

  • The Health Insurance Fund will finance hospitals only according to the needs of the population

    The Health Insurance Fund will not finance all newfound hospitals and will base its decisions on the National Health Card, which will have an obligatory nature. It will list the needs of the regional population. This was the bottom-line decision of the Parliament when adopting the amendments to the Law on Medical Institutions.

    GERB listened to the promise of Prime Minister Borisov to provide support for the health reform of Minister Petar Moskov. The most important changes which concern the funding of hospitals will be solved with the regulations and methodologies of the Health Ministry. It will depend on the Health Minister whether the NHIF will refuse hospital contracts and which hospitals will that be, and whether the government and private hospitals will be forced to unite and for what. Currently Bulgaria has twice as many hospital beds as the EU, and according to the statistics, every fourth Bulgarian is hospitalized once a year, and in practice such people are subjected to treatment not necessarily or even needlessly.

    The National Health Card will have an obligatory nature. It will describe by districts the population medical attention needs. How treatment needs in specialties and hospitals will be determined will be recorded in the methodology of the Health Ministry. The Fund will not finance all institutions in the regions where there are more hospitals than population needs. The criteria by which the NHIF will decide with whom to form a contract and who will remain without funding, will be described in an ordinance. Minister Moscow claims that hospitals that provide comprehensive treatment and do not focus only on well-funded activities by the NHIF will receive priority funding.

    The law provides that the treatment which paid by the NHIF is divided into two packages – Basic and Additional. For the diseases of the Basic package, a comprehensive treatment of which will be provided, the Health Fund will only enter into contracts with hospitals or groups of hospitals that can provide this. Minister Moskov explained that his idea of comprehensive care will be enacted into an ordinance for cancer, the most common cardiovascular diseases and for some rare diseases starting next year. The aim is to have comprehensive care provide for the whole Basic package within the next 3 years.

    The proposal of the Health Minister was the care in question to be provided in one place, i.e. either in a hospital or a group of hospitals. But the majority adopted a softer text according to which hospitals will able to enter into contracts with each other to receive funding from the NHIF for complex care, without merging.

    The idea is, for example, in cancer patient treatment to have at any stage a guarantee for surgery, chemotherapy and radiotherapy, and not to receive surgical treatment in one hospital, and infusions – in another, where the person arranges the stay by himself. The NHIF would not pay all hospitals for the reported treatment covering 3 clinical pathways, and would enter into a single contract for all the treatment needed in one. That is, either all pathways would be paid for, or none. Hospitals would have to arrive at an understanding whether to group into holding companies or unions under the Trade Act, or to enter into contracts among themselves and decide who would receive how much funding.

    The opposition is concerned that if the state, municipal and private hospitals begin to make associations this would lead to siphoning money. But according to Moskov, the idea is that hospitals, dealing only with chemotherapy, for example, would not be able to receive money directly from the Fund, as well as that consolidating would help downsize the administration.

    The idea which caused protests in the summer – that oncology, psychiatric and skin outpatient facilities should merge with the other hospitals – was dropped once and for all. Hospital accreditation will be required in order to land a contract with the NHIF, as it is now, and directors of hospitals are still required to have a qualification in Health Management.

    What will the packages contain?

    By the 15th of September it should become clear what the Basic package would contain and what the Additional one would contain, said Deputy Health Minister Vanyo Sharkov. The diseases from the Basic package would be the main priority and, according to the promises of Moskov, there would be 100% guaranteed funding for them, while those from the Additional will receive less money than now and the treatment would have to wait. The Basic package would include child and maternal health, strokes, cardiology, cardiac surgery and interventional cardiology, traumatology and neurosurgery. Regarding the Additional package what is clear for the time being is that it would contain the “pimples” in the words of Sharkov – i.e. the non-essential diseases. Most one-day eye surgery would be transferred from hospital to outpatient care. The Basic package was also not defined in a law, and the determining of its contents was left entirely to the Ministry of Health.

  • September 1, 2015

    For the first time the Republic of Bulgaria, as a Member State of the EU, will be the reference country in the decentralized procedure (DCP) for Marketing Authorisation for a medicinal products with applicant Tchaikapharma High Quality Medicines Inc., Bulgaria. The concerned parties in the procedure are Austria, Greece, Portugal, Romania, Slovakia and the Czech Republic.

    As a reference party to the procedure the BDA will assess the dossier for Marketing Authorisation for medicinal products (fixed combination) with active ingredients ramipril and amlodipine. A team of the BDA will prepare evaluation reports, including questions to the applicant at any stage of the procedure. The evaluation will be consistent with the requirements of current Pharmacopoeia (Ph.Eur.), the Guidelines of the International Committee on Harmonization (ICH) and European guidelines on quality, safety and efficacy of medicinal products.

  • July 14, 2015

    Bulgarian Drug Agency issued a new Marketing Authorisation to Tchaikapharma High Quality Medicines Inc. for the medicinal product for treatment of diabetes mellitus Aroba 100 mg tablets.

    Aroba contains the active substance acarbose, and belongs to the group of medicines called alpha-glucosidase inhibitors. It is used as supplement treatment concomitantly with diet in patients with diabetes and for the prevention of type 2 diabetes in patients with demonstrated impaired glucose tolerance. The dosage should be individualized for each patient by the doctor as the efficacy and tolerability vary from individual to individual.

    ATC code: A10BF 01

    More information about Aroba can be found here.