BRAZIL

On February 17, Colombia’s Ministry of Health issued Resolution 213 of 2022, which creates the Guide for the Elaboration of Drug Risk Management Plans. The regulation is intended for holders and applicants of sanitary registrations that market chemically synthesized drugs with new active pharmaceutical ingredients and biological drugs. The provisions of the resolution will come into force as of February 15, 2023. 

Through the resolution, the Ministry establishes the parameters for the elaboration of Risk Management Plans. The purpose of these plans is to document the risk management system necessary to identify and minimize the significant risks of a drug. They should identify the safety profile of the drug, with emphasis on potential important risks and safety concerns. They should also provide for the planning of pharmacovigilance activities to characterize and quantify risks. 

The evaluation and approval of the Risk Plans will be the responsibility of the National Institute for Drug and Food Surveillance – INVIMA, which may require information to convert the plan into a tool containing effective and verifiable measures and strategies associated with the use and commercialization of the drug. The agency’s website will have a space for the dissemination of the summary of the Risk Management Plan from 2023.