Mexico Profile Updated
The Mexico profile in ClinRegs has been reviewed and updated with the following information, which is current as of October 31, 2025:
- 2025 data protection legislation and related information regarding public information transparency and access, strengthening private party rights, and regulating public data processing (See Personal Data Protection)
- 2025 Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) regulation and updated guideline to simplify research protocol authorization procedures (See Scope of Assessment, Regulatory Fees, Scope of Review, the Clinical Trial Lifecycle topic, the Sponsorship topic, Manufacturing & Import, and Quality Requirements)
- 2025 COFEPRIS regulations establishing guidelines to recognize World Health Organization (WHO) and/or reference regulatory authority prior approvals when granting health registrations, evaluating research protocols, and approving good manufacturing practice (GMP) certificates (See Scope of Assessment, Submission Process, Timeline of Review, Manufacturing & Import, and Quality Requirements)
- Updated DIGIPRiS guidelines and related sources (See Scope of Assessment, the Clinical Trial Lifecycle topic, and Specimen Import & Export)
- Additional and updated forms related to preparing and submitting partial and final technical-descriptive reports (See Progress Reporting)
- Updated COFEPRIS protocol authorization and amendment/modification fee information (See Regulatory Fees)
- 2025 guidelines on applying to COFEPRIS for investigational product and human specimen import/export permits (See Regulatory Fees, Timeline of Review, Manufacturing & Import, and Specimen Import & Export)
- Additional and updated information on COFEPRIS’s Comprehensive Service Center (CIS)’s Electronic Procedures Portal and related services (See Submission Process)
- Additional details regarding the age of majority (See Children/Minors)
- Updated information on COFEPRIS’ placement within the Ministry of Health (See Regulatory Authority)
- Updated ethics committee installation template from the National Bioethics Commission (CONBIOÉTICA) (See Forms)
- Additional references to resources related to clinical trial review and implementation were added throughout the profile where appropriate
Sources Added During this Update:
(Legislation) General Law on the Rights of Girls, Boys and Adolescents (GenChldRtsLaw - Spanish) (English-GenChldRtsLaw – Google Translation) (Amended through May 27, 2024)
Congress of the United Mexican States
(Legislation) General Law on Transparency and Access to Public Information (PDP-Trnspcy - Spanish) (English-PDP-Trnspcy – Google Translation) (Effective March 21, 2025)
Congress of the United Mexican States
(Regulation) Agreement Establishing Simplification Actions for (Research Protocol Authorization) Procedures Carried Out Before the Federal Commission for the Protection against Health Risks, as Indicated Therein (Agrmnt_ResProtProcs - Spanish) (Effective May 19, 2025)
Ministry of Health
(Regulation) Agreement Establishing the Criteria for the Authorization of Research Protocols in Human Beings that have Prior Authorization from a Foreign Regulatory Authority (Agrmnt_FRAAuth - Spanish) (Effective June 17, 2025)
Ministry of Health
(Regulation) Agreement Issuing the Guidelines for the Presentation of Documents that Guarantee Good Manufacturing Practices for Drugs, Medicines and Medical Devices that Accompany Applications for New Health Registrations, their Extensions and Modifications (Agrmnt_GMPCert – Spanish) (Effective March 21, 2025)
Ministry of Health
(Standard) Mexican Official Standard NOM-027-SSA3-2013, Regulation of Health Services, which Establishes the Criteria for the Operation and Care in the Emergency Services of Health Care Facilities (NOM-027-SSA3-2013 - Spanish) (Effective November 28, 2013)
Ministry of Health
(Standard) MODIFICATION of Various Points of the Mexican Official Standard NOM-059-SSA1-2015, Good Manufacturing Practices for Medicines, Published on February 5, 2016 (NOM-059-SSA1-2015-Mod – Spanish) (Effective December 3, 2025)
Ministry of Health
(Guidance) Guidelines for Serving the Public at the Comprehensive Service Center of the Federal Commission for Protection Against Sanitary Risks (G-CIS - Spanish) (Effective December 15, 2021)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Guidance) Modification to the Guidelines for Serving the Public Users of the Comprehensive Service Center of the Federal Commission for Protection Against Health Risks Published on December 14, 2021 (G-CISMod - Spanish) (Effective September 27, 2022)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Article) Simplified Procedures for Health Regulations: COFEPRIS Transforms More than 30 Procedures (MEX-87 - Spanish) (English-MEX-87 – Official Translation) (July 14, 2025)
Arochi & Lindner
(Article) Mexico: From 2010 to 2025 – Evolution of the New Federal Law on the Protection of Personal Data held by Private Parties (MEX-95) (March 26, 2025)
Baker McKenzie
(Document) Health Verification Certificate for Establishments Conducting Clinical Trials (MEX-93 - Spanish) (Revision 07) (Last Updated March 2025)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Document) Instructions for Filling Out the Committee Registration Application Form (MEX-102 – Spanish) (English-MEX-102 – Google Translation) (Date Unavailable)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Form) Guide for the Presentation of Information in Final Technical-Descriptive Reports (MEX-94 - Spanish) (English-MEX-94 - Google Translation) (Revision 01) (2025)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(International Guidance) E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files (MEX-101) (Last Updated July 2025)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(Press Release) COFEPRIS Strengthens Regulation of Clinical Trials with the Issuance of 16 ICH Efficacy Guidelines (MEX-85 - Spanish) (September 24, 2025)
Federal Commission for the Protection against Health Risks (COFEPRIS), Ministry of Health
(Webpage) Advanced Electronic Signature (e.firma) (MEX-83 - Spanish) (Current as of October 31, 2025)
Tax Administration Service (SAT
(Webpage) Clinical Trials (MEX-88 - Spanish) (September 29, 2025)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Webpage) Health Verification Instruments. Health Verification Reports (MEX-92 - Spanish) (October 10, 2025)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Webpage) Procedure for Renewing Research Ethics Committees (RECs) (MEX-100 – Spanish) (September 9, 2024)
National Bioethics Commission (CONBIOÉTICA), Ministry of Health
(Webpage) Terms of Use DIGIPRiS Medicines (MEX-89 - Spanish) (English-MEX-89 – Google Translation) (September 5, 2024)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Webpage) Testing Laboratories and Interchangeability and Biocomparability Units (Authorized Third Parties) (MEX-98 - Spanish) (September 4, 2025)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
Sources Revised During this Update:
(Legislation) Federal Law on the Protection of Personal Data Held by Private Parties (PDP-PrivateLaw - Spanish) (English-PDP-PrivateLaw – Google Translation) (Effective March 21, 2025)
Congress of the United Mexican States
(Legislation) General Law on the Protection of Personal Data Held by Obligated Subjects (PDP-Public - Spanish) (English-PDP-Public – Google Translation) (Effective March 21, 2025)
Congress of the United Mexican States
(Regulation) Agreement by which the Administrative Units and Decentralized Bodies of the Ministry of Health are Organized (MOH-Org - Spanish) (Effective March 28, 2025)
Ministry of Health
(Regulation) Agreement on Supplies and Importation with Authorized Regulatory Authorities [Abridged title] (Agrmnt_RegHlthSup - Spanish) (Effective September 2, 2025)
Ministry of Health
(Guidance) Application for Modification to the Permit to Import into the National Territory or the Export Permit for Cells and Tissues Including Blood, its Components and Derivatives, as well as Other Human Products (COFEPRIS-01-030) (G-ImprtPermitMod - Spanish) (Last Updated July 17, 2025)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Guidance) DIGIPRiS User Manual: Platform Access, Profiles and Roles (G-DIGIPRiS-SystAccess - Spanish) (English-G-DIGIPRiS-SystAccess – Google Translation) (May 19, 2025)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Guidance) DIGIPRiS User Manual: Submission of New Protocols (COFEPRIS Key Code-04-010) and Amendments (COFEPRIS Key Code-09-012) (G-DIGIPRiS-Prots&Amdts - Spanish) (English-G-DIGIPRiS-Prots&Amdts - Google Translation) (May 19, 2025)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Guidance) Health Permit for the Importation of Medicines that are not or do not Contain Narcotics or Psychotropic Substances, and that are not Registered (COFEPRIS 01-010-A) (G-UnregDrugImprts - Spanish) (Last Updated July 15, 2025)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Guidance) Permission to Export Cells and Tissues from the National Territory including Blood, its Components and Derivatives, as well as Other Products of Human Beings (COFEPRIS 01-024) (G-ExprtPermit - Spanish) (Last Updated July 15, 2025)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Guidance) Permission to Import Cells and Tissues into the National Territory, including Blood, its Components and Derivatives, as well as Other Products of Human Beings (COFEPRIS 01-025) (G-ImprtPermit - Spanish) (Last Updated July 16, 2025)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Guidance) Request for Authorization of Research Protocols in Human Beings Modality A (Medicines, Biologics, and Biotechnologies); Modality B (Medicines (Bioequivalence Studies)); Modality C (New Resources, Except for Pharmacological Ones); Modality D (Risk-Free Research (Observational Studies)) (G-HumResProt - Spanish) (Last Updated June 18, 2025)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Guidance) Request for Modification or Amendment to the Research Protocol Authorization (COFEPRIS-09-012) (G-ResProtocolAmd - Spanish) (Last Updated March 5, 2025)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Document) Applicable Rates for Health Records, Health Licenses, Import Permits, Foreign Trade Export Procedures, and Other Permits or Authorizations - January 1 to December 31, 2025 (MEX-11 - Spanish) (English-MEX-11 – Google Translation) (December 30, 2024)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Document) Data Protection Laws and Regulations Mexico 2025 (MEX-4) (July 21, 2025)
Diaz, Abraham; Alcocer, Giustavo; and Huitron, Carla; Olivares
(Form) Example of Installation Record of the Research Ethics Committee (MEX-27 - Spanish) (English-MEX-27 – Google Translation) (2024)
National Bioethics Commission (CONBIOÉTICA), Ministry of Health
(Form) Guide for the Presentation of Information in Partial Technical-Descriptive Reports (MEX-31 - Spanish) (English-MEX-31 – Google Translation) (Revision 00) (2025)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health
(Webpage) Comprehensive Service Center (CIS) (MEX-37 - Spanish) (May 19, 2025)
Comprehensive Service Center, Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health