Blog & Resources Camargo Blog November 19th, 2007

New MAPP for FDA Accepting Alternate Compendia for CMC Standards

On 11/3/2007 FDA issued a new MAPP* entitled “Acceptability of Standards from Alternative Compendia (BP/EP/JP)”. Although directed at new drugs, one can probably argue that the policy should also apply to the Office of Generic Drugs. Up to now, reviewers seemed arbitrarily accepting or denying the use of BP, EP and JP grade excipients and API’s when a USP standard existed, even when the foreign standard was ‘better’ or ‘the same’. With the issue of this MAPP, sponsors need to justify the use of the alternate compendia and the reviewers must consider accepting them if warranted.

Good news for all of us who work with drugs from the US and foreign countries!

*Manual of Policies and Procedures

Categories: 505(b)(2) Development / CMC

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