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Published on 5 August 2011

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EMA to extend collaboration with global counterparts

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The European Medicines Agency (EMA) and its international partners are to increase collaboration, following two successful pilot studies aimed at ensuring the enhancement of drug quality and safety worldwide.

The US Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration (TGA) were two of the leading bodies to participate in a good clinical practice inspection pilot programme, which involved the exchange of over 250 documents relating to 54 medicines and 13 collaborative inspections of clinical trials.

The second study – titled the joint active pharmaceutical ingredients inspection pilot programme – was a two-year collaboration involving the EMA, FDA, TDA and other participating authorities from France, Germany, Ireland, Italy and the UK.

Over the course of the 24-month pilot phase, the participants shared surveillance lists and found 97 common sites, resulting in the exchange of nearly 100 inspection reports and nine joint inspections.

The EMA released the following statement, following the success of the pilots:

“Based on the positive experience in the two pilots, the agencies have agreed to continue with their collaboration on inspections, taking into account the experiences and lessons learned during the pilot phases.”

EMA



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