WHO on Multisource Product Variations

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] WHO’s Expert Committee on Specifications for Pharmaceutical Preparations has prepared “general guidance on variations to multisource pharmaceutical products” (Annex 10), intended to guide national authorities in creating a viable approach to regulating CMC post-approval changes (PAC) to either an original or generic pharmaceutical marketing authorization (MA). It is not intended to be applicable for biologics. After a glossary of the key terminology and a discussion of general considerations, the guide provides a three-tiered approach to categorizing variations – major, minor and notification – reflective of the process in the US and Europe. Sections follow discussing when new dossiers are required, considerations for changing product information and labelling, and PAC documentation and review procedure considerations.
[/membership]