FDA & EMEA to increase cooperation

By Nick Taylor

- Last updated on GMT

The Transatlantic Economic Council (TEC) has set out its vision of
how increased cooperation between the US and European Union can
improve the pharmaceutical regulatory process.

Guidelines for collaboration between the US Food and Drug Administration (FDA), the European Commission and the European Medicines Agency (EMEA) were agreed at the TEC's second meeting. With the regulatory bodies having to monitor an increasingly diverse global industry, the TEC believes it makes sense for the big regulatory bodies to pool resources. One specific aspect of this broad policy is the launching of a pilot scheme for joint FDA and EMEA inspections of pharmaceutical manufacturing facilities in the US and EU. In addition it is proposed that the two regulatory bodies undertake joint inspections of active pharmaceutical ingredient (API) facilities in countries outside of the EU and US. Doubling up on inspections should ensure high standards and present a united front but may not be practical for all facilities given the increasing regulatory burden. Consequently another pilot scheme will try to cultivate an increasingly fluid flow of information between the FDA and EMEA. This entails the sharing of inspection schedules, results and information on inspected manufacturing sites between the two regulatory bodies. Given that regulatory bodies, in particular the FDA, are being stretched thin by their increasingly challenging global remit this cooperation could play an important role in easing the pressure. Through this cooperation the regulatory bodies should be better equipped to keep tabs on API production plants and ensure facilities are adhering to good manufacturing practices. This increased vigilance in inspecting both at home and abroad is intended to raise regulatory standards and increase the security of the supply chain. Beyond this the regulatory bodies will be collaborating on updating their guidelines regarding when it is necessary for a pharmaceutical product to have a dedicated manufacturing facility. The success of this should become clearer in the first quarter of 2009 when the EU guidelines are published for public consultation. The FDA is currently going through the process of clarifying its stance on this issue.

Related topics: Regulatory & Safety, QA/QC

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