Amendments to decree 344
July 14 2023
decree 344
The ongoing amendments to Decree 344, aimed at streamlining the renewal and modification procedures for marketing authorizations of medicinal products and ensuring swift access to essential medicines, are now entering their third phase.

Recently, a new draft proposing amendments to the decree has been shared with industry associations, signaling progress in the regulatory process. The proposed changes primarily focus on legal-administrative adjustments and minor-risk modifications. Depending on the specific nature of the matter, these adjustments may be implemented through notification, automatic changes, or subject to prior review.

Stakeholders and interested parties have been given the opportunity to provide their feedback on the draft. Comments on the proposed amendments can be submitted until July 16 to the following email addresses: and

It is worth noting that Decree 344 has already undergone previous amendments. Decree 1036 of 2022 introduced modifications to Articles 16 and 29, specifically targeting the acceleration of certain procedures outlined in Decree 344, such as those related to advertising authorizations. However, the subsequent Decree 322 of 2023 postponed the implementation of these accelerated procedures (except for administrative-legal amendments and renewals for biological medicinal products) until specific guidelines are issued.

To allow for a smooth transition, the entry into force of the amended decree has been extended until September 2023 for quality, safety, and efficacy variations, shortages, stock-outs, and ex officio reviews. These measures reflect the authorities’ commitment to ensuring a well-regulated and efficient system for medicinal products, benefiting both industry and the public.

Original source in Spanish.