Decree to revise drug regulation

The Ministry of Health has introduced Decree 1474, which amends Decree 334 of 2022 and aims to revise critical aspects of drug regulation. The decree introduces key changes to the drug registration process, such as the obligation to notify the non-commercialization of a product and procedures for marketing authorization (MA) amendments, all aimed at streamlining bureaucratic processes. A major highlight is the indefinite validity of Drug MAs with a focus on compliance monitoring. Existing registered medicines with a five-year validity will now have an indefinite validity, as long as they comply with the approved conditions. To maintain this validity, the MA holder must submit an application to INVIMA.

In addition, depending on their nature, changes to the MA may be treated as a notification of novelty, as an automatic variation or may require prior authorization.

The decree obliges the MA holder to report immediately any situation or incident that may impede commercialization or lead to temporary suspension or permanent withdrawal of the medicinal product from the local market. Those opting for permanent withdrawal must give six months’ notice, while temporary non-commercialization must be reported within thirty days. This requirement is intended to allow sufficient time for risk analysis and to ensure timely and efficient responses to prevent potential market shortages.

While the regulation has been in force since 8 September, a two-month transition period will facilitate the development of guidance and stakeholder consultation.