- The changes to the review and authorization processes contemplate administrative simplification and further strengthening of the health surveillance processes.
- With this simplification, the deadlines for requests for authorization of research protocol in humans are reduced from 90 days to no more than 30 business days.
The Federal Commission for the Protection against Sanitary Risks (Cofepris), announced changes in its processes of attention to requests for authorization of research protocol in human beings, and thus, encourage the research of medicines, biological, biotechnological, new resources and in bioequivalence studies.
The changes to the review and authorization processes contemplate administrative and regulatory simplification, empowering the surveillance processes in the development of clinical trials.
This optimization process recognizes the work of the Ethics, Research and Biosafety committees. Likewise, Cofepris will strengthen supervision in the development of clinical trials, maintaining sanitary control of the protocols.
With this simplification, the terms are reduced to no more than 30 business days, depending on the procedure entered. The terms will be established according to the following:
• The authorizations of new protocols go from 90 days to 30 days.
• Amendments with an impact on the conduct of the study go from 90 to 20 days.
• Administrative amendments will be reduced from 90 to 10 days.
The changes focus on 6 homoclaves, or types of procedures, all focused on applications for authorization of clinical trials in humans. The homoclaves applied to this optimization are:
• COFEPRIS-04-010-A: pharmaceutical, biological and biotechnological
• COFEPRIS-04-010-B: Medicines (bioequivalence studies)
• COFEPRIS-04-010-C: New resources such as materials, grafts, transplants, prostheses, physical, chemical and surgical procedures.
• COFEPRIS-04-010-D: Research without risk, such as observational studies and those that do not perform any intervention on the variables.
With this new method of strategic cells, focused on streamlining procedures without sacrificing scientific rigor, it is proposed to end the delayed authorization procedures for new clinical trials aimed at drug research, bioequivalence and low risk in less than three weeks.
With this, Cofepris encourages innovation, which brings benefits such as access to new therapies during the development of the study, more research in universities and health institutes and a more agile registration process with greater monitoring.
Cofepris commitment is to use and strengthen its scientific and technical capacities to guarantee compliance with health regulations, putting the health of the population at the center of this institution.