EMA publishes ICH Q12 Draft with Deadline for Comments

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

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 ich@ema.europa.eu.

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 - 28 September 2018
CFDA, China - 18 December 2018
FDA, US -15 December 2018
Health Canada, Canada - to be notified
MFDS, Republic of Korea - October 2018
MHLW/PMDA, Japan - 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.