P-10 Development of a Joint Regulatory Review Framework for COVID-19 Therapies in the Caribbean: A Practice Paper
Author(s):
J Austin , M Zheng , J St John ,R Extavour
Year of Presentation:
2023
Objective: To conduct a review of the regulatory environment and stakeholder perspectives towards developing a framework for consultative and/or joint reviews of medicines and vaccines in CARICOM.
Methods: A SWOT analysis and a risk assessment analysis were undertaken, and supplemented by interviews with focal points of 6 CARICOM countries and with representatives of a Central American mechanism for work-sharing, to explore the regulatory landscape, identify anticipated challenges, and to inform the joint review framework.
Results: Based on the existing verification review process for COVID-19 vaccines, findings of the analyses, and feedback from focal points, the framework was developed as “fit-for-purpose” with three stages of implementation: Process 1 (consultation after CRS Caribbean Regulatory System (CRS) review for COVID-19 medicines and vaccines), Process 2 (Member State request for review and consultation), and Process 3 (work-sharing among Member States for medicines to treat prevalent conditions).
Conclusion: The proposed joint review framework as a staged process of consultations or work-sharing reviews of medicines / vaccines is a welcome initiative. It will require further discussion with Member States, and agreement on participation, harmonization of requirements, adoption of outcomes, and timely market decisions by participating Member States. This approach may be considered by other resource-constrained country groups considering collaborative or work-sharing approaches.