Clinical Trial Applications in Mexico: decentralization and acceleration of protocol approval

With the goals of accelerating the development of new molecules that improve the healthcare and quality of life of Mexicans, and of stimulating clinical investigation, pharmaceutical innovation and foreign investment in the country, on the 5th of March 2014, the COFEPRIS has authorized the eight National Institutes of Health and the High-Specialty Hospitals Coordinating Commission to pre-approve clinical investigation protocols.

clinical trial phases

Once the Institutes pre-revise the clinical protocol, it would take the COFEPRIS about 20 working days to grant the final approval. This decentralizing action is expected to reduce the total approval timelines to just a month: a third of what it takes today.

During the official designation of the entities, Mikel Arriola, head of the COFEPRIS said: “This is a great window of opportunity. We want more investigation in Mexico, in Mexican patients, we want more and better treatments to be developed and we wantbig pharma companies to invest more in investigation and innovation, taking advantage of the scientific excellence of the Institutes”. He also clarified that this decentralization don’t transfer regulatory functions, given that the last word on the approval of the protocols will stay with the COFEPRIS.

The nine public institutions that have been assigned as Authorized Third Parties to pre-revise clinical protocols are:

  • Instituto Nacional de Cancerología. (National Institute of Cancerology)
  • Instituto Nacional de Cardiología. (National Institute of Cardiology)
  • Instituto Nacional de Ciencias Médicas y Nutrición. (National Institute of Medical Sciences and Nutrition)
  • Instituto Nacional de Rehabilitación. (National Institute of Rehabilitation)
  • Instituto Nacional de Neurología y Neurocirugía. (National Institute of Neurology and Neurosurgery)
  • Hospital Infantil de México. (Mexico Children Hospital)
  • Instituto Nacional de Salud Pública. (National Institute of Public Health)
  • Instituto Nacional de Enfermedades Respiratorias. (National Institute of Respiratory Diseases)
  • Comisión Coordinadora de Institutos Nacionales de Salud y Hospitales de Alta Especialidad. (High-Specialty Hospitals Coordinating Commission)

The remaining five institutes and high-specialty hospitals will be able to join the scheme automatically and immediately.


About Maria I. Guaia
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