Leveraging Regulatory Reliance to Streamline Management of CMC Post-Approval Changes: Industry insights from Multi-Country Reliance Pilots

Data from the industry-driven reliance pilot projects for Chemistry, Manufacturing and Controls (CMC) Post-approval Changes (PACs) as presented in this paper have indicated the potential to reduce review and approval timelines by 12-80% in the cases discussed herein. This may help improve the availability of medicines and vaccines for patients globally. Such outcomes are attributed to collaboration between regulators and the pharmaceutical industry. This article describes the approach taken for these pilots and presents data from the initial eight PAC reliance pilots that have completed their reliance procedure and also includes information from three pilots still underway. All pilots focused on major and moderate PACs (EU Type II and Type IB variations). Data collected included product modality, types of CMC changes, involvement of regulatory authorities and approval rates. The article also explores the benefits and possible limitations of reliance approaches for CMC changes and considers steps towards making reliance pathways a routine option for global CMC post-approval changes. As pilot programmes progress, future publications may expand on these observations with data from other ongoing and planned pilot projects.