The 13th Annual Collaborative Registration Procedure (CRP) Meeting will be held virtually from 7 to 9 October 2025. Organized by the Regulation and Safety (REG) Unit, this meeting aims to build the capacity of National Regulatory Authorities (NRAs) in regulatory reliance and enhance the effective implementation of CRP for both initial marketing authorizations and post-approval changes.
Meeting objectives include:
- Strengthening the understanding of NRAs, Stringent Regulatory Authorities (SRAs), and other stakeholders on the principles, benefits, and practical application of reliance mechanisms, including the Collaborative Registration Procedure;
- Advocating for the use of available CRP guidelines, tools, and implementation resources to support participating NRAs in effective and efficient CRP adoption;
- Sharing best practices and experiences from NRAs on integrating CRP into national systems, including the use of templates and system adaptations to facilitate reliance-based registration;
- Promoting the use of CRP for streamlining post-marketing changes and ensuring continued access to quality-assured medical products throughout their lifecycle;
- Reviewing pending CRP applications in participating countries and identifying actions to support their timely finalization;
- Training NRA representatives on conducting abridged dossier assessments and verifying Good Manufacturing Practices (GMP) compliance as part of reliance-based evaluations;
- Discussing other facilitated product introduction initiatives in the Eastern Mediterranean Region (EMR), including joint assessments and strategies to expand CRP implementation.
This annual meeting serves as a key platform for collaboration, knowledge exchange, and advancing WHO’s efforts to strengthen regulatory systems and improve timely access to quality-assured medical products through reliance pathways.