New leadership

On 16 February 2021 Alejandro Ernesto Svarch-Pérez was appointed as the new head of the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), the Mexican regulatory agency.

According to COFEPRIS, Svarch-Pérez has experience in international medical affairs and administrative matters resulting from his participation in Doctors Without Borders and roles as director general of international relations at the Ministry of Health and national medical coordinator at the National Welfare Institute, among others.

New sources of information

With the change of leadership at COFEPRIS, various new sources of information have become available for regulated companies and the public in general – including:

  • weekly webinars (known as 'EducaPRIS' and 'InnovaPRIS') relating to trending health topics and matters concerning COFEPRIS's functions and processes, including:
    • the electronic system for scheduling appointments required for procedures and submitting documents with COFEPRIS;
    • the importation of medicines and medical supplies for personal use;
    • the importation of cannabis for research;
    • healthy food and its production;
    • free sale certificates;
    • health verifications by the Health Operation Commission; and
    • the Mexican innovation model;
  • podcasts, available via Spotify;
  • a biweekly electronic magazine, which reports:
    • relevant actions taken by COFEPRIS regarding the regulatory framework;
    • decisions regarding the Molecules Committee;
    • new marketing authorisations; and
    • pharmacovigilance actions; and
  • a public report of the decisions taken by the committee in charge of the approval of new molecules (eg, treatments for COVID-19 and influenza and HIV and leukaemia medicines).

Comment

The addition of the new communication channels as well as COFEPRIS's intention to provide data and facilitate and simplify the information provided to the public constitutes a milestone in the regulator's behaviour (at least for the past four years).

From a technological point of view and considering the impact of COVID-19 on the authorities' activities and communication, these new tools show COFEPRIS's inclination to adapt to a new era and develop new methods to reach the Mexican population and regulated agents.

These initiatives revive COFEPRIS's image and provide hope to the regulated industries and life sciences lawyers.