EUROPEAN MEDICINES AGENCY NEWS IN BRIEFS
January 1st, 2013 THE EUROPEAN Medicines Agency (EMA) has released a paper on how to create and revise a pharmacovigilance inspections programme -http://www.ema.europa.eu/docs/en_GB/document_library/Work_Instruction_-_WIN/2013/01/WC500137333.pdf*It has maintained fee reductions for approving orphan medicinal products - http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/02/WC500102327.pdf*EMA has also released submission deadlines for 2014 and 2015 for PIP applications, applications for waivers and answers to requests for information on application modification ...
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