NEWS

Medical-Devices'

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...

Azerbaijan-Pharmaceutic'

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 ...

pharmaceutical'

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...

Azerbaijan-industrial-park'

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...

Global Pharmaceutical Regulatory Affairs Summit'

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...

Hungary-spends-EUR-on-hospital developments in Budapest'

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...

piluli'

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...

news-belarus'

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...

new-Albania'

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...