1. Pink Sheet

ICH Q12 Experts Develop Four-Tier Scheme For Harmonizing Post-Approval Changes

 
• By Joanne S. Eglovitch

Ambitious effort to enable fuller, quicker rollout of post-approval manufacturing changes progressed at ICH meeting in Lisbon, participants told recent conferences. Much of the focus of ICH Q12 discussion was on harmonized reporting categories so manufacturers could make more changes before obtaining approval – and in some cases without even seeking approval.

Representatives of regulatory authorities and industry groups from around the world have reached general agreement on a regulatory template for smoothing out minor differences in how the pharmaceutical industry manufactures drug products for different countries.

Global manufacturers have long complained about the necessity of juggling multiple variations of drug products made using various combinations of...

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