This Briefing provides an overview of how advisory committees can be used to support the regulatory decision-making process and considering the context of Latin American regulatory systems, aims to better understand the operation of Colombia´s Reviewing Commission (Comisión Revisora), an advisory body created to advise the Ministry of Health together with the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA).
Based on our analysis, several recommendations can be considered to optimise the effectiveness of the Comisión Revisora and to help address unmet medical needs:
- Focusing the activities of the Comisión Revisora to selected types of innovative products
- Using external expert advisors for specific therapeutic areas
- Having the Comisión Revisora serve in a truly advisory capacity and not as an assessment body
- Optimising the flow of information between the Comisión Revisora and INVIMA to help reduce delays.
Considering INVIMA´s relevance as a PAHO regional reference agency, its active participation in ICH and the importance of improved access to innovative therapeutic treatment options, additional recommendations have emerged:
- Optimise the regulatory landscape by facilitating the submission and efficient assessment of dossiers for unmet medical needs.
- Promote, develop, and maintain evaluation guidelines and requirements that are aligned with international standards.
- Increase communication and discussions with sponsors, as recommended by WHO and ICH international practices.
- Strengthen processes that accelerate access to innovative medicines for unmet medical need, particularly using reliance mechanisms.
- Reinforce INVIMA´s path towards international convergence and harmonisation with best international practices.
If you have any questions or comments on this Briefing, please don’t hesitate to get in touch with Mario Alanis: email@example.com