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Why Industry Says Global Post-Approval Complexity Must Change

 
• By Joanne S. Eglovitch

Post-approval nightmares shared in biopharmaceutical CMC strategy session. One firm's 'impossible' task: making a drug 55 different ways for 105 countries.

A few of the people who must manage the extraordinarily complex process of winning regulatory approval to improve pharmaceutical manufacturing processes for global markets shared their experiences at a recent forum on post-approval manufacturing changes.

Speaking at a July 21-22 California Separation Science Society (CASSS) CMC Strategy Forum in Gaithersburg, Md., the industry officials explained why it can take years for them to roll out...

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