COLOMBIA

On August 27, the Colombian Ministry of Health published a draft resolution that reforms the requirements for processing health registrations for chemically synthesized drugs. It proposes to modify the Manual of Good Laboratory Practices for Quality Control of Pharmaceutical Products and the Guide containing the criteria and requirements for the study of Bioavailability and Bioequivalence (BD/BE in Spanish) of drugs. Comments and observations can be sent until Friday, September 10 to the e-mail [email protected].

According to the draft, the presentation of BD/BE studies will be required for the first processing of the sanitary registration of chemically synthesized drugs. However, once the registration has been obtained, it will not be necessary to submit the aforementioned studies again when applying for a new renewal.

On the other hand, it is proposed that INVIMA accept BD/BE studies from other reference authorities that were not previously recognized in the country, such as health agencies certified by the Pan American Health Organization as National Reference Authorities level IV, which includes, for example, ANVISA of Brazil.