MEXICO

On December 2, the Federal Commission for the Protection of Sanitary Risks (COFEPRIS in Spanish) held an event where it gave more details regarding the incorporation of the entity to the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH). The entity explained that the adaptations are still in the initial stages but that it will eventually open a series of spaces for dialogue with the private sector to explain the scope of the initiatives. Likewise, COFEPRIS published in the Official Gazette the guidelines for the attention of procedures related to COFEPRIS in the Integral Services Center (CIS in Spanish), which will become effective on December 15.

COFEPRIS explained that it is working on the harmonization of its regulations with those recommended by the ICH, while assuring that the incorporation of the entity will improve access to medicines for the population, while at the same time improving technical, operational and regulatory capacities. Regarding the regulatory changes that this incorporation entails, the entity explained that its application will not be linear or automatic, but progressive and based on the national reality. In this sense, the entity explained that it will work on points such as: the optimization of regulatory processes to which pharmaceutical products are submitted, the homologation of technical criteria for the authorization of products, and the improvement of good clinical practices and then good pharmacovigilance practices.

Regarding the guidelines published by COFEPRIS, these seek to inform the public about the services offered by the Integral Service Center (CIS) and the request for appointments for the purpose of submitting and receiving the corresponding documentation before COFEPRIS. Among the services offered are the reception of procedures, delivery of resolutions issued by the administrative units of COFEPRIS, information on the presentation of procedures and/or request for services, and request for registration in the Single Registry of Accredited Persons (RUPA in Spanish). The procedures under the jurisdiction of COFEPRIS that are received at the CIS are those outlined in the following regulations and include documents for the importation of medicines. In case you require a face-to-face appointment at the CIS, you can access the following link.