Saturday, 8 November 2014

ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle


ICH has just published a Final Concept Paper for a new ICHQ12 guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle.


According the ECA, the reason for the document is: “Currently, there is a lack of a harmonised approach to technical and regulatory considerations for the lifecycle management of pharmaceutical products. Although there are concepts in ICH Q8, Q9, Q10 and Q11 for a more science and risk-based approach for assessing changes across the lifecycle, several gaps exist which hinder a full realization of the benefits intended. The original aim of 'operational flexibility' in post-approval changes has not been achieved yet. The main focus at ICH to date is on early stages of the product lifecycle, especially on development and launch.”

For further details, please see ECA

Posted by Tim Sandle