W-37: Evaluation of ICH Q12 Implementation Readiness

Poster Presenter

Lois Castellano

Senior Specialist, Global CMC Regulatory Affairs
Merck & Co., Inc.
United States

Objectives

This poster will discuss the current regulatory categorization for post-approval changes in ICH regions, and the related challenges for ICH Q12 implementation

Method

Through compilation of publicly available information, this paper examines the current post-approval change regulations across each ICH member and observer country and compares these approaches to the expectations in the ICH Q12 draft guidance. Specifically, it explores the presence of at least one Notification category for moderate to low risk changes.

Results

Review of the ICH member and observer regulations for post-approval CMC changes reveals that several are divergent in categorization level compared to the ICH Q12 draft guidance, with some agencies absent a notification category, and others managing moderate changes the same as high risk, Prior Approval changes.

Conclusion

Regulatory convergence with ICH Q12 guideline will benefit uniformity and clarity of agency post-approval change categorizations. The use of the notification and moderate categories allows applicants to submit and obtain approval for changes quicker, which in turn would support continual improvement and reliability of supply of medicines to patients.