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US FDA Recognizes Eight EU Authorities, Triggers Mutual Recognition Provisions

 
• By Bowman Cox

US FDA recognizes the drug regulatory authorities for eight of the European Union's 28 member states by a Nov. 1 deadline, triggering key provisions of the landmark mutual recognition agreement.

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The US FDA has named the first eight European drug regulatory authorities that it is recognizing under a US/EU mutual recognition agreement reached in March.

It will now be the exception rather than the rule for FDA to inspect pharmaceutical manufacturing facilities in these countries: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK.

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