Accelerated CMC and regulatory efficiency tools can be used to support the approval of medicines in early access programmes, such as emergency medicines and medicinal products for unmet medical need. In such cases, where certain CMC data may be limited at the time of submission, a suite of tools is needed to take CMC off the critical path and facilitate timely approval of critical medicines. In particular, this session will specifically cover the following: 1. Setting of specifications in marketing applications, which may be wider than the release data of the limited number of batches used in clinical trials, by using additional sources of information beyond clinical experience. 2. Submission of complex and innovative raw materials, which has always presented challenges for approval and lifecycle management as these are often proprietary to third party manufacturers and CMC information is not easily available for regulatory submissions. 3. The most beneficial tools for accelerating CMC will be discussed in the context of the lessons learned from recent approvals of Covid-19 vaccines and medicinal products for unmet medical need from an Industry and Regulators perspective. The purpose of this session is to share the experiences from Industry and Regulators on how such efficiency tools can be leveraged to facilitate acceleration of CMC development.
Session Speakers: How to Leverage Pharmaceutical Development and Manufacturing Data for Marketing Authorisations – EMA’s Perspective Veronika Jekerle, EMA-European Medicines Agency, Netherlands
Setting Acceptance Criteria for Release Specification Based on Limited Batch Data David Kirke, BioMarin U.K. Ltd, United Kingdom
Industry Proposal for the Use of QbD and ICH Q12 Principles to Enable Second Sourcing of Raw Materials Kavita Aiyer, Seagen Inc., United States
CMC Lessons Learned from COVID Mark Pellett, AstraZeneca, United Kingdom