ICH Q12 adopted

The International Council for Harmonization (ICH) met in Singapore from 16 – 20 November 2019. The key milestone reached was the adoption of the new ICH Q12 Guideline (Step 4 of the ICH process) on the Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. The new ICH Q12 Guideline including two Annexes is complementary to ICH Quality Guidelines Q8 to Q11. According to ICH, it aims to "promote innovation and continual improvement in the pharmaceutical sector, and strengthen quality assurance and reliable supply of product, including proactive planning of global supply chain adjustments".

In order to ensure a standardized approach, the guidance defines the categorization of Post-Approval CMC changes, Established Conditions (ECs), Post-Approval Change Management Protocols (PACMPs), and Product Lifecycle Management (PLCM) concepts. In particular, the guideline emphasizes the relationship between Regulatory Assessment and GMP Inspection.

After the publication of the final Q12 guideline and its Annex documents on the ICH website, the next phase will be the implementation of ICH Q12 across the ICH regions. However, especially in the EU, revision of local regulations (e.g. the EU Variations Regulation) will have to be performed to fully implement the concepts of Q12. Whereas, in the United States, the ICH Q12 guidance is fully compatible with the established legal framework.

In addition, the ICH Assembly revisited a proposal for the revision of the ICH Q9 Guideline on Quality Risk Management. The Assembly approved the Concept Paper Outline, with the revision of ICH Q9 to have a delayed start time in view of other ongoing quality work.

Please read the ICH Press Release for more information.