Colombia makes drug approval more flexible
25 abril 2018

On April 21st, the Executive branch established by decree the state procedure for the registration and supply of new drugs and the renewal of health system licenses. The decree seeks to shorten the approval time of drug licenses. It will come into force December 5th, 2018. Furthermore, the results of the pharmacological evaluations will be available online as of June 20th, 2018.

The decree enables Law Nº 1753/2015 Article 72 to come into force, which allows the National Institute of Surveillance of Drugs and Food (Invima) to register drugs and the Ministry of Health to set prices simultaneously. Hence, the process for a drug to be commercialized is expected to be reduced.

Drug approval and registration procedure

In order for a drug to be traded in Colombia, the Institute of Health Technology Assessment (IETS) must classify drugs in one of the six therapeutic value categories based on the level of safety or efficacy compared to a similar medication; being category 1 more effective than the chosen therapeutic comparator and category 6 as non-classifiable medication.

The new regulation states that drugs will be submitted to a sanitary registry by the National Institute for Surveillance of Drugs and Food (Invima). Simultaneously, the Ministry of Health and Social Protection will have 90 days to set its price.