Mexico has issued various agreements recognising that the requirements imposed by some foreign regulatory agencies for the approval of pharmaceutical products and medical devices are equivalent to those established by national law and regulations.
These agreements include the recognition of approvals issued by:
- the World Health Organization (WHO) prequalification programme;
- the Swiss Medicines Agency;
- the US Food and Drug Administration;
- the European Medicines Agency;
- HealthCanada;
- the Australian Therapeutic Goods Administration; and
- reference agencies recognised by the WHO and the Pan American Health Organization.
While some of these agreements have been around for many years, they have not been widely used, primarily because they did not give applicants a clear advantage with regard to regulatory timing. Requests submitted via these agreements were studied in the same order in which they were received, together with requests that did not have the benefit of an equivalence agreement.
This situation changed – at least on paper – in November 2020, when an agreement was issued in the Official Gazette that included a significant reduction in regulatory times, establishing:
- a term of five business days to issue health records submitted under equivalence agreements;
- a term of three days to issue requirements where incomplete information is provided; and
- the benefit of automatic approval if the deadlines expire.
Despite this agreement, the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) failed to respect the reduced approval times. Various health registration applications have been in process for months, and COFEPRIS has publicly acknowledged severe delays.
In a recent case brought by a pharmaceutical company in response to COFEPRIS's inactivity, the court issued favourable interim measures, holding that:
- there was a likelihood of success on the merits of the company's case; and
- COFEPRIS had to allow the company to carry out the activities associated with the sanitary registry.
It is expected that the court will issue a favourable judgment on the merits, which will give greater solidity to the positive effects of these interim measures.
This strategy can be replicated for the benefit of other pharmaceutical companies, enabling them to speed up their health registration approval processes in similar situations.
For further information on this topic please contact Juan Luis Serrano, Mariajosé Ayala or Rodrigo Calderón at Sanchez-DeVanny Eseverri SC by telephone (+52 55 5029 8500) or email ([email protected], [email protected] or [email protected]). The Sanchez-DeVanny Eseverri SC website can be accessed at www.sanchezdevanny.com.