Peru, Ecuador and Colombia regulate drug health registrations
14 julio 2021

ANDEAN REGION

On July 2, Peru’s Executive Branch amended the Regulations for the Conditional Sanitary Registration of Medicines and Biological Products, in order to simplify the procedures to register and re-register the conditional sanitary registration of pharmaceutical specialties and biological products. It is already in force. Along the same lines, between July 7 and 9, Ecuador’s Executive Branch put a document on drug health registrations out for public consultation. The final version of the initiative will be published in the coming weeks. Finally, the Colombian Ministry of Health published a draft decree to renew and modify drug health registrations. Interested parties may send their comments to [email protected] and [email protected] until July 15. 

The Peruvian decree states that in order to request the re-registration of pharmaceutical specialties, the holder of the conditional sanitary registration must submit a copy of the pharmaceutical product certificate or certificate of free marketing issued by the competent authority of the exporter’s country of origin, taking as a reference the WHO Model, for imported products. In addition, the holder must submit a copy of the Certificate of Good Manufacturing Practices (GMP) of countries with high sanitary surveillance and countries with which there is mutual recognition.

Meanwhile, the document of Ecuador provides detailed and precise information on the requirements that must be attached for the registration, re-registration, approval and modification of the Sanitary Registration of medicines in general. Bioequivalence and Bioavailability studies must also be attached to the application. The presentation of these studies will be mandatory for certain drugs, of which active ingredients such as capecitabine, clonazepam and metformin, used by Roche, should be taken as a reference.

Finally, in Colombia, the Ministry of Health launched a public consultation on July 1 on a draft decree that establishes provisions for renewing and modifying drug health registrations, their review, subsequent control and suspension. It also regulates the advertising of over-the-counter drugs and their marketing on the Internet. The justification of the draft decree highlights the need for a clear and objective regulation regarding the information that can be given on over-the-counter drugs, as well as those sold under prescription.

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