WHO Should Align with ICH on PACs
On Dec. 16, PDA reached out to WHO, regarding the Organization's proposed guidelines for post-approval changes. Overall, the PDA commenting team feels that efforts to align post-approval expectations across jurisdictions is a positive sign in light of the complexity of implementing manufacturing changes impacting multiple regulatory regions. The commenting team further recommended WHO fully align the proposed guidelines with the proposed ICH Q12 guideline on post-approval changes.
PDA's comments can be viewed in full here.