On May 14, the Ministry of Health published a draft regulation establishing a series of health requirements for the manufacture, import, and sale of medication to treat COVID-19. The definitive version of the text is expected to be presented in the short term. On the other hand, the Ministry also issued a resolution establishing clinical medication research protocols in the context of the emergency.
The draft establishes that drug-manufacturing facilities producing medicines declared as vital and unavailable must submit a request to the Colombian Food and Drug Surveillance Institute (INVIMA, for its acronym in Spanish). The request must include details on the product’s composition or qualitative-quantitative formula as well as the description of the manufacturing process and its corresponding commercial packaging, presentations and branding. In addition, the decree regulates cosmetics production, stipulating guidelines for product traceability and donation.
Finally, the Ministry’s resolution establishes provisions for presenting and approving clinical drug research protocols in the framework of the pandemic. In all cases, interested entities must request specific authorization from the INVIMA, which will be in charge of surveillance and monitoring, guaranteeing safe procedures and reviewing the safety reports presented by the research teams. The regulations apply to research centers, educational institutions, sponsors and contracted research organizations.