Final Concept Paper Published by ICH for a new ICH Q12 guideline

ICH has just published a Final Concept Paper for a new ICH Q12 guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle.

The concept paper was published with a view to provide harmonized approach to technical and regulatory considerations for the lifecycle management of pharmaceutical products which was lacking till date. The concepts in ICH Q8, Q9, Q10 and Q11 did not give full information of the benefits of the risk based approach applied across the changes in the lifecycle of pharmaceutical product.

The proposed ICH Q12 Guideline along with ICH Q8 to Q11 Guidelines will provide strategies for the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more efficient manner across the product lifecycle which will be beneficial in the innovation and continuous improvement leading to the better understanding of post approval CMC changes among the regulators.