At the end of last January 2023, Cofepris published on its website and on social networks its Regulatory Certainty Strategy for the pharmaceutical sector, in which they establish 7 commitments with which they want to comply with the regulatory framework, provide clarity and certainty to the user about requirements, processes and evaluation times, and also comply with the commitments acquired by Cofepris as a regulatory member of ICH (International Conference of Harmonization).
The commitments are the following:
1. Installation of a Committee of Good Regulatory Practices. It is intended that all changes in the regulatory framework be coherent and viable, always taking regulatory improvement into account. The Committee will have participation from the public, private and social sectors. Lastly, they plan to have thematic sessions with the regulated sectors involved and the technical teams of Cofepris.
2. Authorization of drug products by recognition. The objective is to establish the criteria and guidelines for reliance procedures.
3. Regulatory harmonization. Its purpose is to comply with the commitments acquired by Cofepris, as a member of ICH. They plan the adoption of various ICH guidelines and the creation of a Standard in Good Clinical Practices, in different periods of time.
4. Digitization as a way of optimization. Implement digital solutions in order to optimize the evaluation of pharmaceutical procedures, reduce the backlog and meet legal deadlines in the evaluation of pharmaceutical products. For example, they are working on developing a platform for processing minor and moderate Modifications to the Registration Conditions, in which an automatic resolution can be obtained.
5. Bioequivalence and biocompatibility studies. The objective is to allow the recognition of bioequivalence and biocomparability studies carried out abroad. They are working on the issuance of a new NOM-177 that establishes the guidelines for the recognition of these studies, in record times.
6. Safe use of Active Pharmaceutical Ingredients (APIs). They intend to generate and publish criteria and guidelines that allow the entry and supply of low-risk APIs manufactured in countries that do not have GMPs or an equivalent document, issued by High Surveillance Regulatory Agencies such as China, India, Pakistan, etc. as long as they comply with the provisions of ICH, PIC/s, etc. This is not intended to deregulate, but to optimize and strengthen health surveillance.
7. Entry of foreign-manufactured biotechnological drugs. The objective is to reduce trade barriers with an impact on the supply of biotechnological medicines in Mexico. It is worth mentioning that vaccines are not contemplated at this point, they will continue being released as before.
Cofepris plans to develop and implement these 7 commitments in a period from the fourth quarter of 2022 to the fourth quarter of 2030.
For all the commitments, it is intended to start their implementation in the first quarter of 2023, with the exception of Regulatory Harmonization, which is planned for the fourth quarter of 2026. With this, it is intended to comply with the international commitments acquired in free trade agreements (TMEC, Pacific Alliance), as well as those acquired with the WHO, ICH and PIC/s.
Since 2022, the digitization of procedures such as Notices of operation and health manager, Request for renewals of registration letters(first and second or subsequent), advertising notices began and this has allowed greater efficiency of the CIS. We hope that in the near future, it will also have an impact on the opinion areas and we can see a greater influx of procedures available with resolution in the CIS, which until now has not increased.
The seven commitments are very ambitious and although they will be presented in the long term, their implementation and operation will simplify many regulatory procedures related to medicines, both for the industry as a user and for Cofepris as the Regulatory Agency, hopefully in the short term.
And above all, they will improve the evaluation of various procedures, generating greater certainty in terms of the times and criteria for evaluation and resolution, which will combat a major problem that Cofepris currently presents, which is the lag in the resolution of procedures. And we are waiting for the Regulatory Certainty Strategy applicable to medical devices, because it is also very important, since it covers a majority of the health supplies that are required for proper patient care and access to new technologies.
