During the current administration, Cofepris has set the objective of promoting clinical research in Mexico.
This subject had not received the necessary attention in the past, and therefore, there is a significant delay in the evaluation and authorization of clinical study protocols that have led to the reduction of clinical research in Mexico as well as the delay of international protocols.
Among the actions that Cofepris has taken to achieve their objective are the following:
1. Launching of the DIGIPRIS platform for Research and Clinical Trials, in December 2023, where users electronically submit clinical studies for evaluation and authorization. The responses to these procedures are also provided electronically through this same portal. With this, Cofepris estimates to reduce the evaluation times by up to 75% and from December 2023 to May 2024, approximately 90 clinical trials have been authorized through this platform.
2. The publication of the draft for PROY-NOM-262-SSA1-2024 Good Clinical Practices. April 24th, 2024. Although it is still a draft, represents a significant progress as it officially implements Good Clinical Practices in Mexico and, above all, it specifies how they will be implemented in clinical research. Because previously they had only been published as guidelines to comply with Good Clinical Practices in research, but a guideline is not the same as a NOM (Mexican Official Norm), that is aligned to ICH and it details what they consist of and how to apply them, in addition to the Publication of the NOM in the DOF (Official Gazette of the Federation) would make its implementation and compliance mandatory for anyone carrying out clinical research in humans in Mexico.
3. In addition, on May 14th, Cofepris published additional measures to optimize and increase transparency in the evaluation process of clinical trials submitted through the DIGIPRIS platform; among which are:
– Recognition of criteria and evaluation results authorized by ethics, research and biosafety committees presented by the applicant.
– Standardization of evaluation criteria for clinical studies, approaching the best clinical research practices established by ICH.
– Optimization of processes in the import permits for health supplies that are required as part of a clinical research, in order to comply with the legal deadlines established for these procedures.
– Publication of the criteria to be assessed in the clinical studies.
With this set of actions, Cofepris demonstrates its determination to increase and attract investments in clinical research in Mexico.
Especially the use of the DIGIPRIS platform has been widely accepted by users and has managed to speed up the evaluation and authorisation of clinical studies, however it is still premature to quantify the impact of this set of actions on the protocols conducted in Mexico. Without a doubt, clinical research is a great area of opportunity for the growth of the country and to progress in access to new therapeutic options and advanced therapies.
