NEWS

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Russia and Bulgaria signed cooperation agreement

Last week, on July 10, 2018, in Sofia Vladislav Shestakov – Director of the State Institute of Drugs and Good Practices, Deputy Head of the State GMP Inspectorate met with Professor Assena Stoimenova, Executive Director of the Bulgarian Drug Agency (Medicines Agency of the Bulgarian Health Minis...

Aurobindo Pharma to acquire Apotex’ businesses in Poland, Czech Republic, the Netherlands, Spain and Belgium

Aurobindo Pharma announced that its wholly owned step-down subsidiary, Agile Pharma B. V. (Netherlands) has entered into an agreement on 13 July 2018 to acquire commercial operations and certain supporting infrastructure in five European countries viz. the Netherlands, Belgium, Spain, Poland and ...

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Slovenia and Romania are the Fastest Growing Markets in Europe

Whilst the latest European Commission 2018 economic growth forecast for the EU stands at 2.3%, a large group of Eastern European countries clearly outpaces its European peers. Slovenia, Romania and Bulgaria lead the pack as shown on the chart below. Growth in the above CEE countries is forecast to ...

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Bulgaria’s Sopharma Trading to grow operations in Serbia

SOFIA (Bulgaria), June 22 (SeeNews) - Bulgarian drug distributor and retailer Sopharma Trading [BUL:SO5] plans to expand its operations on the Serbian market and to become a strategic investor in Southeast Europe (SEE), it said. Sopharma Trading is planning to implement its successful diversified...

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Sun Pharma enters Azerbaijani market

Azerbaijan’s Sumgait city has hosted the groundbreaking ceremony of the first plant for the production of solid drugs. The ceremony was attended by Azerbaijan’s Economy Minister Shahin Mustafayev. During the event, it was noted that products of the plant, which is being built by India’s Sun Ph...

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Poland might not be the first place you associate with biotech, but the country is becoming an emerging hotspot for pharmaceutical companies and biotech startups.

Although Poland has a very strong scientific base in life sciences and medicine, it has not developed a vibrant biotech or medtech sectors. Until recently, no truly innovative products from Poland have been introduced to the global market. The pharmaceutical industry has traditionally been based on ...

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Czech Republic mulls new reimbursement rules for medical devices

The Czech Health Ministry prepared draft amendments to the Public Health Insurance Act, which will introduce new reimbursement rules for medical devices, the Ministry said. The new rules are expected to come into force in January 2019, replacing current regulations that were contested by the Czec...

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Medicines rose in price in Kazakhstan

Medicines in Kazakhstan rose by 7% in 2018 Q1, Energyprom.kz reports. According to 2018 first quarter results, prices for pharmaceutical products rose 2% compared to the previous quarter and by 6.6% on-year. The most noticeable annual price rise was recorded in the hormonal drugs segment - by ...

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Lithuania – Update on ‘Sunset Clause’ Requirements for Medicinal Products

The State Medicines Control Agency on the ground of market monitoring data has compiled the list of medicinal products authorized in the Republic of Lithuania which more than for three years had not been supplied to the Lithuanian market. Following Part 7 Article 14 of the Law on Pharmacy in the ex...

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New payment requirements of a Bulgarian Drug Agency

In February 2018, the Bulgarian Drug Agency (BDA) announced new requirements for fee payments which are important for all applicants, marketing authorisation holders and their representatives. When requesting an administrative service for marketing authorization/registration, variations, renewals o...

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Kazakh domestic pharmaceutical production up 79.8 percent in 2017

ASTANA – The Kazakh pharmaceutical industry increased production of the country’s most popular medications by 73.1 percent with production increasing 79.8 percent over 2016. Prices for pharmaceutical products in Kazakhstan have also increased 6.6 percent over the last 12 months. The production in...

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Romania on the last place in EU for medical drugs consumption

Romania is at the bottom of a European ranking regarding the consumption of medical drugs per capita, but not because they are healthier, but due to the precarious access to therapeutic solutions, according to the Trade Union of Industrial Medical Drugs Producers in Romania (PRIMER). The organisa...

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Falsified meds do not yet impose a serious threat in Hungary and the EU

“Due to strict regulations and legislatory monitoring no falsified or unauthorized medication has entered the legal drug supply chain in Hungary until now, stated the Hungarian Association of Innovative Pharmaceutical Manufacturers (AIPM). This does not mean, however, that obtaining locally u...

Overview of Estonian medicinal products market

Estonian annual drug statistics is based on wholesalers’ quarterly reports. The statistics of human medicinal products includes sales to general and hospital pharmacies and to other institutions, i.e. state and scientific institutions. WHOLESALERS In January 2018 there were 67 wholesalers in Eston...

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Kazakhstan Pharmaceutical and Medical Device Market Trends

The Kazakhstan pharmaceutical and medical device industries are one of the most buoyant sectors of the country’s economy. Over the past three years, the productivity of the indigenous pharmaceutical industry has increased by 42%. In 2017, the value of domestically produced drugs exceeded 73 billion ...

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Regarding medicinal products for which „sunset clause“ may already be applied

The State Medicines Control Agency on the ground of market monitoring data has compiled the list of medicinal products authorized in the Republic of Lithuania which more than for three years had not been supplied to the Lithuanian market. We here with remind that following Part 7 Article 14 of th...

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Serbia – New Perspectives for Pharmaceuticals and Medical Devices

With Serbia making further progress with the EU accession process and the prospect of joining the EU in 2025, it is the country which gets increased attention of international pharmaceutical and medical device manufacturers. "It is the process of joining the European Union that counts and not so mu...

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Azerbaijan, Jordan may jointly produce pharmaceuticals

Azerbaijan offers Jordan to establish a joint pharmaceutical factory, Jordan Economy Ministry said on Feb. 21. Azerbaijan’s Economy Minister Shahin Mustafayev made an offer during the meeting with Jordan Minister of Industry, Trade and Supply Yarub Qudah in the framework of working visit to Jordan....

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NATIONAL MEDICINES VERIFICATION ORGANISATIONS IN EASTERN EUROPE

To protect the EU pharmaceutical market from the entry of falsified medicines, the European Medicines Verification Organisation (EMVO) was created as a joint initiative of EU stakeholders, representing manufacturers, wholesalers and community pharmacists.  According to EU Directive 2011/62/EU pharma...

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Slovakia’s amended tax laws may impact pharmaceutical sector

Slovakia’s approved Amendment to Act no. 595/2003 Coll. on Income Tax (ITA) and approved Amendment to Act no. 222/2004 Coll. on Value Added Tax (VATA), bring significant changes to the tax laws, effective 1 January 2018, which may affect pharmaceutical companies. The most relevant of these changes a...

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PROCEDURES FOR REPORTING THE VOLUME OF MEDICINAL PRODUCT SUPPLIES IN CZECH

The State Institute for Drug Control in Czech Republic (SUKL) has published the information with regard to reporting of registration holder pursuant to Section 33, paragraph 2 of Act on Pharmaceuticals. It draws the attention to the obligations set out in Act No 378/2007 Coll., on Pharmaceuticals an...

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Hungarian budget for meds to increase in 2018

The Hungarian Association of Innovative Pharmaceutical Manufacturers (AIPM) has welcomed the fact that the size of the pharmaceutical budget (the price subsidy for medicinal products available in pharmacies) will increase according to the draft budget for 2018. According to the draft legislation,...

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Drug Evaluation and Reimbursement in Poland

In 2017 the pharmaceutical market in Poland posted a 5.4 percent growth. The industry continues to demonstrate value growth with a total market estimated at EUR9bn. The surge in demand for over the counter medicinal products largely contributed to the sector growth. It is access to innovative pre...

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EMA: Pharmacovigilance Fees to Rise in 2018

The European Medicines Agency (EMA) on Wednesday said it expects fees paid by drugmakers for pharmacovigilance applications to rise by 1.4% in mid-January 2018. Pharmacovigilance fees in in the EU are set by Regulation (EU) No 658/2014, which includes provisions for the European Commission to adj...

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The Code of Ethics of the Association of International Pharmaceutical Manufacturers of the Republic of Kazakhstan was held

On December 8, 2017 in Almaty in a solemn atmosphere, the ceremony of signing the Code of Ethics of the Association of International Pharmaceutical Manufacturers of the Republic of Kazakhstan was held. The signing was attended by the chief specialist of the Department of the Pharmacy Committee of th...

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Distribution of Medical Devices in Croatia

According to industry experts, the medical device market in Croatia was valued at $268 million in 2016. The market demonstrates solid growth and is expected to reach $294 million in 2017. The largest product categories are consumables (24% of the total market) followed by patient aids, dental produc...

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Croatian Pharmaceutical Industry Increases Investments

The pharmaceutical industry has been one of the top economy sectors in Croatia for years. The Croatian pharmaceutical industry is one of the most important and strongest sectors in Croatia, and pharmaceutical companies and medicine wholesale trading companies are near the top of the charts of the...

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Riding Revival in Romania – Opportunities for Pharmaceutical and Medical Device Manufacturers

Pfizer’s recent decision to open a European logistics hub in Romania is a strong evidence of a long term commitment that international pharmaceutical manufacturers are increasingly demonstrating towards the Romanian market and indeed a broader Eastern European region.   Romania continuously improves...

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Growth of import of medicines in the Republic of Kazakhstan

Importers of medicines are trying to restore their positions in the Kazakhstan market, in January-August this year, Kazakhstan imported 16.6 thousand tons of medicines, or 32.9% more than in the same period in 2016. Thus, the volume of imports of medicines exceeded the levels not only in 2016 but al...

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Robust Pharma Regulatory Fundamentals in Slovakia

The regulatory requirements in emerging CEE markets remain challenging for the pharmaceutical and medical device manufacturers alike. Slovakia has earned the reputation of a country with the advanced regulatory environment and well-developed operating systems. As a testimony, Bratislava emerged as ...

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Global Pharmaceutical Regulatory Affairs Summit

Pharma Regulatory Professionals Meeting will take place in Prague on October 24-26, 2017 at Clarion Congress Hotel Read more...

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Overview of Estonian medicinal products market

Estonian annual drug statistics is based on wholesalers’ reports. The statistics of human medicinal products includes sales to general and hospital pharmacies and to other institutions, i.e. state and scientific institutions. WHOLESALERS In January 2017 there were 64 wholesalers in E...

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Poland’s pharmaceutical industry growing in value: report

According to analysts with QuintilesIMS, Poland’s pharmaceutical market will be worth PLN 38.5 billion (EUR 9 bn) by the end of 2017, which marks a 5.4-percent hike year on year. The growing figures are largely determined by an uptick in demand for medicine available over the counter, the authors...

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Kazakhstan – New Regulations for Medicinal Products in the Pipeline

The Ministry of Health in Kazakhstan is introducing changes to the existing legislation for distribution of pharmaceutical products and medical devices with the view to improve regulation of prices and ‘create a patient-oriented drug provision model. According to a new draft law, in October 2018 re...

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Positive Healthcare Spending Dynamics in Poland

The healthcare spending in Poland has been steadily on the rise over the last 3 years. In 2016, the budget of the National Health Fund (NFZ) grew by 3.8% with 4.8% increase expected in 2017. The Polish government is determined to boost the 2018 NFZ budget by PLN5.5bn which would result in a total h...

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Pharma company Janssen invests EUR 1 mln in R&D in Romania

Johnson & Johnson Romania’s pharma company Janssen will invest over EUR 1 million in research and development in Romania. The company has expressed its willingness to collaborate with the local authorities to find new solutions to update the list of reimbursable drugs. Janssen is interested i...

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Armenia’s medicine export expands

Armenian medicine producers work with various countries to expand the geography of medicine export, Albert Sahakyan, the deputy director of “Scientific Center of Drug And Medical Technology Expertise” told Armenpress. According to him, some shifts have already been registered. “About 10% of the d...

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Pharmaceutical giant enters Azerbaijan’s market

A groundbreaking ceremony was held for the first plant for production of solid consistency drugs in Azerbaijan. The plant, which will be commissioned in late 2018, will produce cardiological, nephrological, gastroenterological, diabetic and other medicine necessary for the Azerbaijani market. ...

Overview of Estonian medicinal products market

Estonian annual drug statistics is based on wholesalers’ reports. The statistics of human medicinal products includes sales to general and hospital pharmacies and to other institutions, i.e. state and scientific institutions. Wholesalers In January 2017 there were 64 wholesalers in Estonia and six...

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Romania’s Ministry of Health plans to change the clawback tax

Romania’s minister of health, Florian Bodog, says the government is looking to change the clawback tax, which has attracted criticism from the pharma industry in the past years. The tax had been rolled out in 2009, in a bid to bring more money to the healthcare budget during the crisis period. Au...

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Medical Devices Regulatory Affairs 2017 in Prague

The medical device sector is one of the most complex and challenging business segments of the healthcare industry with close collaboration between science and engineering. The main objective of the regulatory harmonization is to improve the efficiency of national economies and their ability to adopt...

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China-invested joint venture boosts Kazakhstan’s pharmaceutical industry

Kelun-Kazpharm, located in outskirt of Almaty, Kazakhstan, is a Sino-Kazakh pharmaceutical joint venture controlled by a Chinese private company. Since put into operation in July 2014, the venture has not only boosted Kazakhstan’s pharmaceutical industry, but also brought win-win prosperity to Centr...

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Accessibility to new and effective medicine in Latvia is the poorest in Europe

In terms of accessibility and compensation of new and effective medicine, Latvia is on the last place among EU member states, according to Patients W.A.I.T. Indicator published by European Federation of Pharmaceutical Industries and Associations at the end of April. According to the study, patien...

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Minister says French companies wishing to invest in Armenian pharmaceutical and food industries

French companies expressed interest in investing in Armenia’s pharmaceutical and food industries, Minister of Economic Development and Investments Suren Karayan told journalists after a regular Cabinet session today. He said meetings were held with potential French investors during President Sargsya...

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DEFEATING PROPOSED PHARMACEUTICAL STRANGLEHOLD IN POLAND

The Parliament in Poland has been considering new restrictions on the country’s pharmaceutical industry, placing strict limits on who can receive a license to operate a pharmacy, how many pharmacies can be operated by one proprietor, the allowable distance between planned pharmacies and ones already...

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BRINGING 200+ PHARMACEUTICAL REGULATORY AFFAIRS, ESUBMISSIONS AND LABELLING EXPERTS TOGETHER FROM ACROSS THE GLOBE

We would like to extend a very big thank you to everyone who attended this year's Global Pharmaceutical Regulatory Affairs Summit. In the heart of Berlin, industry experts gathered to discuss the latest global regulatory updates for regulatory affairs, eSubmissions and labelling. Continue readin...

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Medbaltica 2017: 10th international medical fair 21-23 September

The Baltics’ major medical exhibition Medbaltica brings together a variety of healthcare professionals, professional associations and manufacturers of medical products from Latvia and other countries. The exhibition marks the development of the healthcare industry as a whole, delivers current news a...

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Ascendis Health to buy Romania’s Sun Wave Pharma for 42.5 mln euro

Ascendis Health Limited CEO Karsten Wellner South African over-the-counter (OTC) healthcare products maker Ascendis Health Limited said on Wednesday it plans to acquire Romanian alternative medicine products distributor Sun Wave Pharma for 42.5 million euro ($47.7 million). The business will be a...

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Industry Trend Analysis – Healthcare Issues Limit Drugmaker Revenues Over Short-Term – APR 2017

BMI View: Azerbaijan's healthcare sector is at an inflection point as it attempts to reform the financing model away from a state-run system to a compulsory healthcare insurance model. Highlighting ongoing challenges for drugmakers operating in Azerbaijan, i n the short term, the country 's populati...

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Transparency Push: EMA to Revise Policy on Document Access

The European Medicines Agency (EMA) on Friday proposed a revision to its policy on accessing documents, extending the scope to include corporate documents, and increasing the publication of clinical data for pharmaceuticals. Since October 2016, EMA has published pharmaceutical trial data via its ...

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Vilnius-based pharmaceutical to produce cutting edge cancer treatment

Sicor Biotech/Teva Baltic, the largest pharmaceutical company in Lithuania, is preparing to begin production of a new active medicinal ingredient to be used in the treatment of cancer. The ingredient, XM21, will be produced in the company’s Vilnius facility from this autumn. As Giedrius Žunda, th...

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Iranian pharma company kicks off construction of plant in Azerbaijan

An Iranian pharma company Monday broke ground on a plant it is building as a joint venture with Azerbaijan. Iran's Darou Pakhsh Pharma Chem is building the $30 million plant in the Pirallahi Industrial Park, the Financial Tribune reports. The plant is projected to be commissioned in two years. D...

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The Pharmaceutical Industry in Figures – Key Data 2016

Thanks to advances in science and technology, the research–based pharmaceutical industry is entering an exciting new era in medicines development: The Pharmaceutical Industry in Figures - Key Data 2016...

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Saneca gets Gov grant to invest in API plant

Slovakian Government has granted Saneca Pharma EUR 1.5m to invest in "green" API manufacturing and anti-abuse technologies for it's opiate-based drugs http://www.in-pharmatechnologist.com/Ingredients/Saneca-gets-Gov-grant-to-invest-in-API-plant...

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CIS Pharmaceutical Forum

The only conference covering the entire CIS pharmaceutical sector including Kazakhstan, Uzbekistan, Moldova, Belarus, Armenia, Georgia, Azerbaijan, Kyrgyzstan, Tajikistan, Turkmenistan & more! More.....

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$74M to be invested in Azerbaijan’s first medicine plant

The Azerbaijani-Russian joint pharmaceutical plant will come to full production capacity in 2020, said Azerbaijan’s Economy Minister Shahin Mustafayev. He made the remarks Nov. 2 during the plant’s groundbreaking ceremony in the Pirallahi Industrial Park. This is Azerbaijan’s first pharmaceuti...

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Kazakhstan and Hungary signed memorandum on expansion of pharmaceutical production

Within the framework of the Kazakh-Hungarian business forum the «Kaznex Invest» JSC, the JSC "International Research and Production Holding "Phytochemistry" and Hungarian company «PannonPharma LTD» signed a memorandum of understanding on organization and expansion of the production of original medic...

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Global Pharmaceutical Regulatory Affairs Summit

Informa Life Sciences’ Global Pharmaceutical Regulatory Affairs Summit, taking place on 27th – 29th October 2015 in Berlin, Germany, combines two previously separate events, ‘Regulatory Affairs in Emerging Markets’ and ‘Global eSubmissions’ to bring you increased networking and 3 highly focussed str...

Central European private spending on health to exceed €21bn

Private healthcare markets in Central Europe are still young markets replete with opportunities. There is substantial demand for such services in the countries analysed in the most recent PMR report “Private healthcare market in Central Europe 2016. Development forecasts for 2016-2021” because of th...

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EMA Releases List of Medical Events for Pharmacovigilance Monitoring

The European Medicines Agency (EMA) has released a list of standardized terms describing medical events it says will be used by the agency and other European regulators to identify suspected adverse events.EMA says the list will assist it and other regulators to prioritize the review of suspected ad...

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Hungary spends 745 M EUR on hospital developments in Budapest

The government has allocated around 235 billion forints (EUR 754.6m) towards the first phase of hospital development and upgrades planned in the capital which are scheduled to begin at the beginning of next year at the latest, the government commissioner for hospital developments told daily Magyar I...

Medicinessafety monitoring : StatusandProspects

Based on the WHO definition pharmacovigilance is "scientific research related to the detection, assessment, understanding and prevention of adverse reactions or any other problems associated with medical drugs." The " thalidomide tragedy" caused creation of pharmacovigilance in EU. During just a fe...

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Changes in pricing of medical products

Belarus: Decree no 228 of 21 June 2016 establishes new rules for pricing of pharmaceuticals, medical devices and medical equipment (“medical products”). The new rules entered into force on 1 July 2016. We are glad to introduce you the most important changes. 1. Sale prices of medical products pr...

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Sales of mid- and high-priced drugs in Russia continue to decline

Sales of mid- and high-priced drugs in Russia are steadily declining, due to the ongoing economic stagnation in the country and the consequences of the financial crisis, reports The Pharma Letter’s local correspondent. According to a recent report, published by the Russian Ministry of Health,...

Czech Pharma Industry Leaders Meet to Discuss New Legislation

Prague, 20 June 1016 - The Prague office of Baker & McKenzie recently hosted the latest in a series of workshops on hot topics and issues that pharmaceutical companies face when doing business in the Czech and Slovak markets. As of 1 July 2016, the newly adopted Contracts Registry Act will co...

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Medical device regulation in the EU and US needs urgent reform, say experts

Patients and clinicians need greater regulatory transparency to make informed decisions about treatment. Medical devices approved first in the European Union (EU) are associated with a greater rate of safety issues, finds a study published by The BMJ. Clinical trial results for many new medical ...

PSUR Repository

The PSUR repository is a single, central platform for PSURs and related documents to be used by all regulatory authorities and pharmaceutical companies in the EU. The PSUR Repository provides an important simplification for marketing authorisation holders allowing them to send all PSURs and related ...

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BNT Baltic Pharma Law Survey 2015

The BNT Baltic Pharma Law Survey 2015 provides actionable insights into the pharmaceutical regulatory  and competition law, pricing, reimbursement and other requirements that are crucial for doing business  in the Baltic states. PharmaLawSurvey2015_TheBalticStates...

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EU Council and Parliamentary Committees Sign Off on New Medical Device, IVD Regulations

The European Council's Permanent Representatives Committee and the European Parliament’s Environment and Health Committee on Wednesday endorsed the agreement reached on the continent’s new medical device and in vitro diagnostic (IVD) regulations, a day after the draft versions of the texts were rele...

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Generic drug market in Central Europe to develop by 3%-6% pa between 2016 and 2021

According to estimates from Poland-based market research group PMR, Poland will be the most rapidly developing… In order to access this content you need to be logged into the site and have an active subscription or trial subscription.  Please login, take a free trial or subscribe in order to contin...

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EFPIA to extend collaboration with Lithuania on pharmaceutical policy

On 22nd April 2016, in Vilnius, Lithuania, EFPIA Director General Richard Bergström and Lithuanian Minister of Health Juras Pozela discussed the implementation of the Stability Agreement concluded between the industry and the Lithuanian authorities in 2014, and running until 2016. They furthermore s...

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Kazakhstan: Common Pharmaceutical Market Of The Eurasian Economic Union

Since the breakup of the Soviet Union, the former Soviet republics have been on a quest for independent development. At the same time, modern trends in international relations and inter-dependence of the post-Soviet economies, once part of a common and centralized economic complex, have prompted the...

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Serbia to sell 25% stake in pharmaceutical giant Galenika

The Serbian economy ministry launched a tender process for the sale of 25% of state-controlled pharmaceutical giant Galenika on April 4, setting the starting price at just €7mn. Galenika was originally listed as one of 502 public companies supposed to be privatised by the end of 2015. However, it...

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Foreign companies show interest in Belarusian pharmaceutical projects

Foreign companies show interest in projects to develop Belarus' pharmaceutical industry, Head of the Belarus President Administration Alexander Kosinets said during his working visit to Vitebsk Oblast on 19 March, BelTA has learned. The official paid a visit to the veterinary drugs company BelVituni...

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Solepharm pharmaceutical company has launched exports to Albania

Latvian pharmaceutical company Solepharm has launched exports to Albania, LETA learned from the company. Solepharm plans to export three of its original products to Albania – Olefar DUO Oil Spray, Artroveron 5 in 1 with Omega, and Pregnafar. Negotiations on cooperation with Albania were launch...

Overview of Estonian medicinal products market

Estonian annual drug statistics is based on wholesalers’ reports. The statistics of human medicinal products includes sales to general and hospital pharmacies and to other institutions, i.e. state and scientific institutions.WholesalersIn January 2016 there were 60 wholesalers in Estonia and six of ...

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Pharma company Lek expands its facility in Slovenia

Pharma company Lek, owned by Swiss multinational Novartis, has expanded its facility in Mengeš, just north of Ljubljana Slovenia, in a project worth EUR 10m. The investment will create an additional 100 new jobs. The project included the construction of cutting-edge new laboratories for development...

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Massive EU funding pouring into Croatian healthcare. EU Giving Half a Billion Kuna for Croatian Hospitals

Ministry of Health published a public call for hospitals on Tuesday, October 2015 to submit their project proposals for investments in day clinics and day surgeries where patients will be able to receive better diagnostic services and be treated using most recent methods. Projects will be financed f...

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Number of pharmaceutical drug approvals hits record high

2015 was a good year for innovation in medicine in both the EU and the US, according to data published on Monday (4 January). The European Medicines Agency (EMA) recommended 93 new products, including generics, up from 82 in 2014. Across the Atlantic, the Food and Drug Administration (FDA) approve...

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PHARM Connect Congress in Budapest, Hungary

PHARM Connect Congress is the largest and most important pharmaceutical and biotechnology business summit in the Central Eastern European and the CIS region, taking place annually in February, in Budapest, Hungary. Since the event’s launch in 2011, the number of participants has reached more than...