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Joint FDA-EMA inspection programme to launch in January 2012

By Gareth Macdonald , 13-Dec-2011
Last updated the 15-Dec-2011 at 17:21 GMT

The FDA and the EMA will begin sharing facility inspection data in their respective territories from January to make better use of resources and reduce drugmakers’ inspection burdens.

The new collaboration builds on the pilot inspection programme the agencies have been trialling for the last few years which, according to results released in August , reduced the number of duplicate inspections and established a master list of active pharmaceutical ingredient (API) supply facilities.

EMA spokeswoman Monika Benstetter told in-Pharmatechnologist.com the new accord goes a step further than the pilot scheme, adding that: “each agency is now relying on its partner for drug manufacturing facility inspection data.”

Australia’s Therapeutic Goods Agency (TGA) – which was a partner in the pilot programme – will not be part of the scheme beginning in January according to Benstetter, who said that it will only involve the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

According to a document issued by the FDA and EMA earlier this month the general approach will to focus on information exchange for sites “already known to each authority “ that “have a history of satisfactory GMP compliance following previous inspections.

The most likely impact will consequently be in the area of routine post-authorisation-surveillance inspections. Pre-authorisation/pre-approval inspections will continue largely unchanged, as by definition the sites are unknown or a specific inspection trigger has been identified. Exceptions nevertheless may be made on a case-by-case basis.”

The plan is to review the collaboration after three years.

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