Pharmaceutical Regulatory

GMPnews.net provides the latest pharmaceutical regulatory news affecting today's business environment, including latest government regulations and court rulings.

The New England Journal of Medicine compared FDA and EMA

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The New England Journal of Medicine compared review times for new therapeutic agents that were approved by the The Food and Drug Administration (FDA) or The European Medicines Agency (EMA) between 201...

To date 101 inspections for compliance with Russian GMP conducted this year

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Vladislav Shestakov, the Director of the Federal Budget-Funded Institution State Institute for Drugs and Good Practices, presented the results of inspectorate activities, its future plans and spoke ab...

Russian Ministry will support the pharmaceutical manufacturing

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“The “odd man out” rule in public procurement of drugs continues to demonstrate its effectiveness,” said Alexey Alekhin, Deputy Director, Department of Pharmaceutical and Medical Industry Development,...

Russian government will permit production of HIV drugs bypassing the patent-holders

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The Russian government is ready to allow the production of anti-HIV drugs bypassing patents of their right-holders. This will be in the form of the federal law, that will officially come into a for...

22% of Russian pharmaceutical manufacturers received GMP certificate

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According to the analytical department of FBI SID&GP, by the end of 2016, 527 manufacturing licenses were effective in the Russian Federation, which corresponds to 566 production sites in 71 regio...

SID&GP will audit 500 enterprises in 2017

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At the XII International Conference "Pharmaceutical Business in Russia: a promising scenario for the development of pharmaceutical market for 2017" Vladislav Shestakov, Director of the State Institute...

Roszdravnadzor will help Russian pharmaceutical products to enter the foreign markets

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According to Head of Roszdravnadzor, Mikhail Murashko, as of now, there are 12 modern laboratory facilities operating in all Russian Federal districts that are capable to carry out quality testing of ...

New measures to support Russian pharmaceutical manufacturers

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Deputy Prime Minister Arkady Dvorkovich instructed the Ministry of Industry, Ministry of Economy and the Ministry of Health to develop additional proposals for new measures to support Russian pharmace...

Guidelines for participants of the drug labeling pilot project were issued in Russia

The Federal Service for Surveillance in Healthcare has published guidelines for participants of the pilot project on drug labeling with control (identification) signs (CIS) and monitoring of certain t...

SID & GP and Kazakhstan National Centre for Expertise of Medicines signed a Memorandum on сoope...

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Оn February 7, 2017, the representatives of Federal Budgetary Institution «State Institute of Drugs and Good Practices» and Republican State Enterprise with the right of economic management National C...

Special Investment Contract will bring the investments to pharmaceutical industry

On February 8, Victor Dmitriev, Director General of Association of the Russian pharmaceutical manufacturers addressed at the meeting of the Health Care Committee hosted by the Franco-Russian Chamber o...

EEC suggests labeling drugs that cost more than 500 rubles with RFID-chips

The idea to label only expensive drugs with special marks was discussed by the Eurasian Economic Commission in January at the working meeting with the business communities of Belarus, Kazakhstan and K...

EAEU will adopt 67 normative documents for the common pharmaceuticals market

Until 2018, the Eurasian Economic Union (EAEU) will adopt 67 “third-level” documents to ensure high quality of safe drugs for the EAEU patients. The list and adoption status of the documents ensuri...

A cartel agreement in public procurement of medicinal drugs was uncovered by OFAS

Moscow OFAS exposed a cartel in more than 100 auctions fort the total amount over 414 million RUB In January 2017, the Office of the Federal Antimonopoly service in Moscow recognized a cartel forme...

Pharmacopoeial Committee of the EAEU as a supranational union has been launched

On the 2nd and 3rd of February, the first meeting of the Pharmacopoeial Committee of the Eurasian Economic Union was held at the site of the Eurasian Economic Commission. It must develop and prepare f...

The pilot project on the implementation of the Risk Sharing Model

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Moscow, the Moscow region and Kaluga will be the pilot regions for testing a new model of the government drugs procurement through the system of “risk-sharing agreement”. This information was announce...