Mexico Profile Updated

May 18, 2023
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Mexico Profile Updated

The Mexico profile in ClinRegs has been reviewed and updated with the following information:

  • Updated contact information for the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS))’s Integral Services Center (Centro Integral de Servicios (CIS)) (See Regulatory Authority and Submission Process)
  • 2023 COFEPRIS fees for submissions related to authorization and/or modification of a human research protocol for medicines, biological, and biotechnological investigational products (See Regulatory Fees)
  • Additional contextual legal information related to mental health and research (See Mentally Impaired)

Sources Added During this Update:

(Legislation) Political Constitution of the United Mexican States (MexConstitution - Spanish) (Amended through November 18, 2022)
Congress of the United Mexican States

(International Guidance) International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MEX-22) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(Webpage) ICH Guideline Implementation (MEX-2) (Current as of May 17, 2023)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Sources Revised During this Update:

(Legislation) General Health Law (GenHlthLaw - Spanish) (Amended through March 24, 2023)
Congress of the United Mexican States

(Document) Applicable Rates for Health Records, Health Licenses, Import Permits, Export Procedures, and Other Permits or Authorizations - January 1 to December 31, 2023 (MEX-11 - Spanish) (December 27, 2022)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) COFEPRIS - Integral Services Center (CIS) (MEX-37 - Spanish) (March 18, 2022)
Integral Services Center, Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) Request for Authorization of Research Protocol in Humans for Medicines, Biologicals and Biotechnologies (MEX-75 - Spanish) (Current as of May 17, 2023)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) Research Ethics Committees (MEX-57 - Spanish) (April 4, 2023)
National Bioethics Commission, Ministry of Health

(Webpage) VigiFlow - Training and Guidance (MEX-44) (Last Updated January 24, 2023)
Uppsala Monitoring Centre, World Health Organization

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