ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management - Scientific guideline

Globalisation of the supply chain and market for medicinal products has resulted in a growing number of different procedures, rules and regulations which MA Holders must follow whenever changes to chemistry, manufacturing and controls (CMC) are needed. This guideline provides a globally agreed framework to facilitate the management of such post-approval CMC changes in a predictable and efficient manner across the product lifecycle. A globally 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 pharmaceutical sector, strengthening quality assurance and improving supply of medicinal products.

This guideline addresses the commercial phase of the product lifecycle (as described in ICH Q10); and it both complements and adds to the flexible regulatory approaches to post-approval CMC changes described in ICH Q8(R2) and Q10 Annex 1.

Refer to the Note on EU implementation of ICH Q12 (EMA/CHMP/ICH/78332/2020) for further details on the implementation of this guideline in the EU.

Keywords: Pharmaceutical development, quality, lifecycle management, risk assessment, control strategy, enhanced approach, established conditions, post-approval change management protocol, pharmaceutical quality system, variations