EMA news in brief

Published: 29-Jan-2013
Regulatory

The latest bulletins from the European Medicines Agency


The European Medicines Agency (EMA) has released a paper on how to create and revise a pharmacovigilance inspections programme.

See www.ema.europa.eu/docs/en_GB/document_library/Work_Instruction_-_WIN/2013/01/WC500137333.pdf

EMA has also maintained fee reductions for approving orphan medicinal products.

See www.ema.europa.eu/docs/en_GB/document_library/Other/2011/02/WC500102327.pdf

The Agency has also released submission deadlines for 2014 and 2015 for PIP applications, applications for waivers and answers to requests for information on application modification plans.

See www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2013/01/WC500137664.pdf

In addition, the Agency has released a chart of its organisation.

See www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500017948

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