A draft version of ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) was issued in November 2017, and the goal is to have a final version by November of this year.

A harmonised approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the biopharmaceutical sector, strengthening quality assurance and improving supply of medicinal products.

This guideline will provide guidance on a framework to facilitate the management of post-approval CMC changes in a more predictable and efficient manner across the product lifecycle. It will also allow regulators to better understand a firm’s pharmaceutical quality systems for the management of post-approval CMC changes, she said.

This guideline provides a framework to facilitate the management of post-approval CMC changes in a more predictable and efficient manner. It is also intended to demonstrate how increased product and process knowledge can contribute to a reduction in the number of regulatory submissions. Effective implementation of the tools and enablers described in this guideline should enhance industry’s ability to manage many CMC changes effectively under the firm’s Pharmaceutical Quality System (PQS) with less need for extensive regulatory oversight prior to implementation. The extent of operational and regulatory flexibility is subject to product and process understanding (ICH Q8 and Q11), application of risk management principles (ICH Q9), and an effective pharmaceutical quality system (ICH Q10).