COFEPRIS announces changes in clinical trial procedures and approves use of new oncology drugs
7 abril 2021

MEXICO

On April 1, the Federal Commission for Protection Against Health Risks (COFEPRIS, in Spanish) announced changes in its processes for handling applications for authorization of clinical trials of drugs in humans. The main measure will be the reduction of processing times, which will be reduced from 90 to 20 days, depending on the case. With this measure, the entity seeks to “encourage the research of medicines, biologics, biotechnology, new resources and bioequivalence studies”. The decision is already in force.  Likewise, the New Molecules Committee (NMC) of COFEPRIS approved the use of Cabozantinib, Goserelin, Nivolumab, Bevacizumab and Pembrolizumab in different cancer treatments.

The changes in the area of clinical trials focus on six homoclaves or types of procedures, all of which are oriented towards authorization requests for said trials in human beings. Among them, the COFEPRIS-04-010-A (biological and biotechnological medicines) and COFEPRIS-04-010-B (medicines -bioequivalence studies-) protocols stand out. With this simplification, the deadlines are reduced from 90 to no more than 30 working days, depending on the procedure entered. For example, in the case of authorizations for new protocols, the deadlines are reduced from 90 to 30 days; for amendments with an impact on the conduct of the trial, from 90 to 20 days; and for administrative amendments to research procedures, from 90 to 10 days.

On the other hand, the approval of the NMC will allow these drugs to be used for new therapies and treatments. Thus, Cabozantinib can be used for the treatment of renal cell carcinoma; Goserelin for breast cancer; Nivolumab for the treatment of hepatocellular carcinoma; Bevacizumab can be used as a biocompatible biotechnology; and Pembrolizumab can be used for esophageal or gastroesophageal junction carcinoma.  The Committee’s opinions will be integrated into a dossier and will be submitted to the entity’s Health Authorization Committee for the definitive authorization of these drugs.

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