Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation; Final Guidance for Industry

Dear Dr. Ramanadham, PDA appreciates the opportunity to respond to the draft ICH Q12 guidance Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. PDA applauds the overall intent outlined in ICH Q12 and the emphasis put on concepts discussed and envisioned in ICH Q8 through to ICH Q11. Particularly, PDA is especially pleased to see language related to post approval change comparability protocols (PACMPs), the importance of an effective pharmaceutical quality system (PQS), risk-based approach to changes, leveraging process and product knowledge to negotiate Established Conditions (ECs) and reduction in the number of regulatory submissions. In addition, this proposal and framework for a harmonized approach with respect to technical and regulatory considerations for lifecycle management and use of the product lifecycle management (PLCM) document is most welcome. If implemented as intended by regulators and industry alike ICH Q12 can help facilitate enhanced continual improvement and innovation and reduce the number of drug shortages that today are aggravated by the global regulatory complexity, including the ICH regions. See attached file(s) for additional detailed comments.