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EMAUKEU

EMA pushes its transparency initiative forward

24.02.2012 - The European Medicines Agency (EMA) will publish information about all drugs under review, beginning on March 1. On a monthly basis the company will issue a list disclosing the international non-proprietary name and therapeutic areas of each product under review as well as information on the type of salt, ester or derivative of the active ingredient.

Until now, EMA has published information just about orphan drugs under review. Information on other products will not be released until the Committee for Medicinal Products for Human Use (CHMP) has issued an opinion. The plan is part of the agency ’s new policy on transparency and access to documents. The agency will also assume more responsibility in the field of pharmacovigilance. Up to now, the EMA focused its post-marketing drug safety monitoring on the 568 centrally authorised medicines for human use. But as of mid-July, the EU drug watchdog will stepwise include pharmacovigilance data from nationally authorised medicines. The newly formed Pharmacovigilance Risk Assessment Committee (PRAC) will be responsible for the implementation of the new European drug safety rules.

http://www.european-biotechnology-news.com/news/news/2012-01/ema-pushes-its-transparency-initiative-forward.html

EbolaEUFrance

30.09.2014 In the face of the Ebola outbreak sweeping the West African countries, the EMA has started to review investigational treatments for the deadly virus disease.

FinancingSwitzerlandGermanyNetherlandsFrance

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ResearchGermany

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FinancingNetherlands

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BusinessGermany

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FinanceSwitzerland

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PoliticsEU

15.09.2014 Jean Claude Juncker, the European Commission President-elect revealed his new Commissioners last week, whilst announcing a change in the units dealing with medicines, medical devices and health technology.

BiosimilarsGermanyFrance

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FinancingNetherlands

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Clinical TrialsUKSweden

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No liability assumed, Date: 01.10.2014