Joint GMP inspections by EMA and FDA discussed as part of TTIP

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Joint GMP inspections by EMA and FDA discussed as part of TTIP

INICIO/Informes | Posted 02/12/2016 0 Post your comment

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) could be carrying out joint inspections for good manufacturing practices (GMPs) as early as January 2017.

The news comes as part of a report from the European Commission (EC) on the 15th round of negotiations for the Transatlantic Trade and Investment Partnership (TTIP) between the European Union (EU) and the US.

The EC report states that ‘The state-of-play and the organization of the evaluation of the US and the EU GMP inspectorates were discussed. In light of the progress achieved, the conclusion of a mutual recognition agreement of Good Manufacturing Practices (GMPs) inspections, by January 2017, is under consideration.’

The EC does add, however, that there are ‘a number of matters still to be agreed/discussed between the Parties, notably as regard the scope of the provisions and operational implementation’.

The report also goes on to say that the EU and US proposals with respect to the pharmaceutical sector ‘have been put side by side in order to identify commonalities’. Areas identified for collaboration included implementation of international standards, medicinal products authorization and antimicrobial resistance. While the exchange of confidential information between regulators and regulatory cooperation were also discussed.

Some groups, however, have warned against provisions in the TTIP which they believe could further delay access to generics [1].

Reference
1. GaBI Online - Generics and Biosimilars Initiative. TTIP could further delay access to generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 2]. Available from: www.gabionline.net/Policies-Legislation/TTIP-could-further-delay-access-to-generics

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Source: Europa