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The EMA and FDA announce joint initiative to collaborate on generic medicines bioequivalence applications

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have announced a joint initiative to share information on inspections of bioequivalence studies.19 Dec 2013

The initiative follows the successful implementation of the initiative on good clinical practice (GCP) inspections which started in 2009 and could help in the building of a global regulatory network for the approval of generics.

The initiative will cover studies submitted to the EMA, the FDA and the regulatory authorities in some EU member states. These bioequivalence studies are conducted when generic drug makers want to enter the market. One of the conditions governing approval of generic medicines is successful demonstration that the generic drug is 'bioequivalent' to the originator drug. 

This initiative will also introduce a measure that will allow joint inspections of facilities where these bioequivalence studies are conducted; this aims to "streamline" inspection operations amongst the countries taking part and will facilitate the exchange of relevant information and ensure bioequivalence inspection resources are used more efficiently.

The joint initiative will be governed by confidentiality arrangements established between the European Commission, the EMA, interested EU members states and the FDA.

The EU member states initially involved are France, Germany, Italy, the Netherlands and the United Kingdom. Additional member states are expected to join the initiative in the future.

Since in the EU a significant number of generic marketing authorisations are obtained through the Mutual Recognition/Decentralised/National procedures, the involvement of the EU Member States is considered essential for the success of this expansion.

Fergus Sweeney, head of the EMA’s Inspections and Human Medicines Pharmacovigilance Division, said: “The progress of this initiative is testimony to increased cooperation and the hard teamwork of the inspection staff of all our agencies, helping us to better leverage our respective inspection resources. Globalisation of clinical trials means that we all rely on each other to assure the quality of bioequivalence clinical trials, and data from these, on which the approval of generic medicines, and therefore the health of EU and American patients, rely.”