As reported before the ICH published the draft of Q12 in December 2017 for public comment. Now, the European Medicines Agency, EMA, published the draft Guideline on technical and regulatory considerations for pharmaceutical product lifecycle management including its Annexes for comment. The Deadline for comments is December 18, 2018. Comments should be provided using the EMA template. The completed comments form should be sent to firstname.lastname@example.org.
The new guideline has been developed to complement the existing ICH Q8 to Q11 guidelines, especially to enable full realization of more flexible regulatory approaches to post-approval CMC changes. The guideline applies to pharmaceutical drug substances (i.e., active pharmaceutical ingredients) and pharmaceutical drug products, including marketed chemical and biotechnological/biological products. The guideline also applies to drug-device combination products („Drug-delivery products“) that meet the definition of a pharmaceutical or biotechnological/biological product.
According to ICH the deadlines for comments in other ICH regions are the following:
ANVISA, Brazil - Deadline for comments by 28 September 2018
CFDA, China - to be notified
FDA, US - to be notified
Health Canada, Canada - to be notified
MFDS, Republic of Korea - Deadline for comments by October 2018
MHLW/PMDA, Japan - Deadline for comments by 30 July 2018
Swissmedic, Switzerland - to be notified
For more information please visit the ICH website.
Just one month before the end of the comment period the ECA will organize the conference ICH Q12 - Product LIfe Cycle Management in Berlin, Germany. There you will have the opportunity to discuss questions and comments regarding the draft document directly with speakers from the ICH Q12 Expert-Group.