Cofepris will no longer be recertified by PAHO, but by WHO

Since the two previous six-year terms, Mexicans have been understanding the importance of having a serious and high-level health regulatory agency of reference (ARN) because it implies that it monitors well and prevents us from health risks, but also that it allows us to access products and safe, effective and quality inputs.

“Effective regulatory systems are an essential component of health systems and contribute to innovation and desired public health outcomes,” says the World Health Organization (WHO).

And it was clear to us for years that it was important to certify and revalidate Cofepris by the Pan American Health Organization (PAHO) as a level 4 reference agency, which was the highest rank granted by said body.

Hence, among the experts it has been concerned every time in this administration measures have been announced that seemed to reduce the demands of imported drugs, but in the end Cofepris has assumed its role with rigor. And the closure, ignorance and lack of skill of the first head appointed by the current Government, the pediatrician José Novelo, also generated great distress, from which among specialists the risk that Cofepris would not maintain its RNA level was taken for granted. OPS.

The appointment this year of Alejandro Svarch to the title of Cofepris generated great expectations, and to date it is evident that he has taken his position seriously and has been forming a team of professionals who are making efforts not only to maintain the level of recognition earned but also go further.

Miriam Loera, international director of Cofepris, explains that the current Cofepris does not seek to recertify itself as RNA level 4 of the PAHO specific for the Americas, because it decided better to raise the requirement and submit to the WHO.

It is the Global Benchmarking Tool (GBT), within which Mexico is seeking to qualify and in this, for now, it helps to have the ownership of the northern chapter of the Conference of the Pan American Network for the Harmonization of Pharmaceutical Regulation ( PARF). It is an opportunity, says Loera, to seek to strengthen scientific technical cooperation with his US counterparts FDA and Health Canada.

So Cofepris is not itself in a recertification process, but rather – the official shares us – it is looking to other regulatory agencies to strengthen itself technically and scientifically and achieve self-sufficiency, especially in a post-covid world. And it is that one of the main lessons learned by health agencies is that the way to facilitate access to health supplies is by standardizing processes is by promoting harmonization and regulatory convergence among all countries.

The GBT assesses all aspects of the operation, from pharmacovigilance processes, post-marketing licenses and in general the maturity of the regulatory system. And now all countries will be evaluated under the same criteria, and that is why for Svarch and his team it is important to take Cofepris there.

It is interesting that as part of this process it should strengthen its communication links not only with academia and other public institutions but also with the private sector, specifically its regulated ones.

It must also be recognized that having become a member of ICH, which promotes the harmonization of good clinical regulatory practices, specifically for health surveillance of regulation of clinical laboratories for research, is an important step where in the region only Mexico and Brazil currently have it.

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Maribel Ramirez Coronel

Journalist on economics and health issues

Health and Business

Communicator specialized in public health and the health industry. Studying a master’s degree in Health Systems Administration at FCA of UNAM.

Founder in 2004 of, a concept on women’s health. I am passionate about researching and reporting on health, innovation, the science-related industry, and finding an objective business approach to each topic.

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