Mexico Profile Updated

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

• Details for electronically submitting research protocol authorization requests via DIGIPRiS, the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS)’s Digital Research and Clinical Trials Platform (See Submission Process)
• Guidelines and related resources from 2024 providing submission requirements and COFEPRIS review details for research protocol authorization and protocol modification/amendment requests (See Scope of Assessment and the Clinical Trial Lifecycle topic)
• Additional details on sponsor requirements related to insurance and compensation for injury or death (See Insurance & Compensation)
• Additional details on sponsor requirements related to monitoring and premature trial suspension (See Risk & Quality Management)
• Additional details on sponsor requirements related to electronic data processing and records management (See Data & Records Management)
• Additional details on informed consent requirements (See Documentation Requirements and Required Elements)
• Guidelines for Research Ethics Committees, Research Committees, Biosafety Committees, and Hospital Bioethics Committees (See Ethics Committee and Oversight of Ethics Committees)
• 2024 guidelines and related resource on applying to COFEPRIS for human specimen import/export permits (See Specimen Import & Export)
• Safety reporting guidance and resources on VigiRam, e-Reporting Industry platform, and pharmacovigilance (See Safety Reporting)
• Additional requirements and related resources on drug interchangeability tests for biosimilar biotechnological drugs (See Scope of Assessment)
• Additional guidance and details for investigational products in regard to drug importation, investigational brochure, quality management, labeling, handling, and record requirements (See the Investigational Products topic)

Sources Added During this Update:

(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 Products of Human Beings (COFEPRIS-01-030) (G-ImprtPermitMod - Spanish) (Last Updated February 7, 2024)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Guidance) Application for Registration of a Research Ethics Committee – A) Initial Registration (CONBIOETICA-00-003-A) (G-RECReg - Spanish) (Last Updated December 17, 2020)
National Bioethics Commission (CONBIOÉTICA), Ministry of Health

(Guidance) Application for Registration of Hospital Bioethics Committee - New Registration (CONBIOETICA-00-001) (G-CHBReg - Spanish) (Last Updated January 24, 2023)
National Bioethics Commission (CONBIOÉTICA), Ministry of Health

(Guidance) Application for Renewal of Registration of the Research Ethics Committee – B) Renewal (CONBIOETICA-00-003-B) (G-RECRegRenew - Spanish) (Last Updated December 17, 2020)
National Bioethics Commission (CONBIOÉTICA), Ministry of Health

(Guidance) DIGIPRiS Online Regulation: Comparison of Documents (G-DIGIPRiS-DocComp - Spanish) (English-G-DIGIPRiS-DocComp – Google Translation) (July 30, 2024)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Guidance) DIGIPRiS Online Regulation: Frequently Asked Questions (G-DIGIPRiS-FAQs - Spanish) (English-G-DIGIPRiS-FAQs – Google Translation) (July 30, 2024)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Guidance) DIGIPRiS: Research and Clinical Trials - Guide for Requesting New Protocols and Amendments (04-010 and 09-012) (G-DIGIPRiS-Reqs&Amdts - Spanish) (English-G-DIGIPRiS-Reqs&Amdts – Google Translation) (Date Unavailable)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Guidance) DIGIPRiS User Manual: DIGIPRiS Registration (G-DIGIPRiS-Regis - Spanish) (English-G-DIGIPRiS-Regis – Google Translation) (Date Unavailable)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Guidance) DIGIPRiS User Manual: System Access, Profile Creation and Roles (G-DIGIPRiS-SystAccess - Spanish) (English-G-DIGIPRiS-SystAccess – Google Translation) (December 1, 2023)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Guidance) Guide for the Application of Human Research Protocols (COFEPRIS 04-010) on the “DIGIPRiS: Research and Clinical Trials” Platform (G-DIGIPRiS-ResProts - Spanish) (English-G-DIGIPRiS-ResProts – Google Translation) (Date Unavailable)
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 February 7, 2024)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Guidance) Registration Request for Committee Modality C. Biosafety Committee (COFEPRIS-05-038-C) (G-BiosafetyReg - Spanish) (Last Updated October 26, 2022)
Federal Commission for the Protection against Sanitary Risks (COFEPRIS), Ministry of Health

(Guidance) Report of Suspected Adverse Drug Reactions (COFEPRIS-04-017)  (G-ADR-PatientRpt - Spanish) (Last Updated August 6, 2024)
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 (COFEPRIS-04-010-A) (G-HumResProt - Spanish) (Last Updated February 22, 2024)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Guidance) Request for Authorization of Research Protocols in Human Beings Modality B: Medications (Bioequivalence Studies) (COFEPRIS-04-010-B) (G-BioequivStud - Spanish) (Last Updated February 22, 2024)
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 February 22, 2024)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Guidance) Request for Registration of Research Committee (COFEPRIS-05-038-B) (G-ResCommReg - Spanish) (Last Updated October 26, 2022)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS)

(Regulation) Agreement Amending the Various Provisions by which the General Provisions for the Integration and Operation of Research Ethics Committees are Issued and the Hospital Units that Must Have Them in Accordance with the National Bioethics Commission Criteria, Published on October 31, 2012 (REC-Op-Amd - Spanish) (Effective December 11, 2020)
Ministry of Health

(Decree) Decree Issuing the General Law on the Rights of Girls, Boys and Adolescents, and Amending Various Provisions of the General Law on the Provision of Services for the Care, Attention and Comprehensive Development of Children (ChildRts - Spanish) (Effective April 13, 2014)
Ministry of Health

(Standard) Mexican Official Standard NOM-012-SSA3-2012, MODIFICATION of the Mexican Official Standard NOM-177-SSA1-2013, which Establishes the Tests and Procedures to Demonstrate that a Drug is Interchangeable (NOM-177-SSA1-2013-Mod - Spanish) (Effective September 16, 2023)
Ministry of Health

(Standard) Mexican Official Standard NOM-177-SSA1-2013, which Establishes the Tests and Procedures to Demonstrate that a Drug is Interchangeable (NOM-177-SSA1-2013 - Spanish) (Effective November 19, 2013)
Ministry of Health

(Standard) Modification to the Mexican Official Standard NOM-220-SSA1-2016, Pharmacovigilance Installation and Operation (NOM-220-SSA1-2016-Mod - Spanish) (Effective October 1, 2020)
Minister of Health

(Article) Communique 02/2024 - Cofepris will Consolidate Digital Transformation in the First Half of 2024 (MEX-108 - Spanish) (January 7, 2024)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Article) Communique 66/2024 - An Opinion Model is Presented that Optimizes and Makes Transparent the Evaluation of Clinical Trials, Promoting Research in our Country (MEX-96 - Spanish) (May 14, 2024)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Press Release) Joint Statement - Cofepris' New Digital Research and Clinical Trials Platform Sets the Standard for Regulation (MEX-97 - Spanish) (December 6, 2023)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) and Ministry of Foreign Affairs

(Press Release) Press Release 105/2023 - Cofepris Transforms Regulatory Policy: Agility in the Registration of Generic and Biosimilar Drugs (MEX-120 - Spanish) (September 28, 2023)
Federal Commission for the Protection against Sanitary Risks (COFEPRIS), Ministry of Health

(Document) e-Reporting Industry User Manual (MEX-117 - Spanish) (Version 2.0) (February 2022)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Document) Evaluation Document for the Request for Authorization of Research Protocols in Human Beings, COFEPRIS-04-010 Modalities A, C, and D (https://www.gob.mx/cms/uploads/attachment/file/935570/C_dula_Autorizaci_n_COFEPRIS-04-010-A__C__D_07-24.pdfMEX-84 - Spanish) (English-MEX-84 – Google Translation) (Version 1.1) (July 30, 2024)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Document) General Information on the Authorized Third Party Process (MEX-121 – Spanish) (English-MEX-121 – Google Translation) (Last Updated March 2013)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Document) Instructions for Filling out the Form for the Import or Export of Human Products (MEX-116 - Spanish) (English-MEX-116 – Google Translation) (Date Unavailable)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Document) VigiRam: What Is It? (MEX-119 - Spanish) (English-MEX-119 – Google Translation) (Date Unavailable)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(International Guidance) ICH Guideline E2B (R3) on Electronic Transmission of Individual Case Safety Reports (ICSRs) – Data Elements and Message Specification – Implementation Guide (MEX-79) (Step 5 Version) (July 2013)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(International Guidance) ICH Harmonised Tripartite Guideline: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) (MEX-80) (Step 5 Version) (October 27, 1994)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(International Guidance) ICH Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7) (MEX-81) (Step 5 Version) (November 10, 2000)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(International Guidance) ICH Harmonised Tripartite Guideline: Pharmacovigilance Planning (E2E) (MEX-82) (Step 5 Version) (November 18, 2004)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(Not Available Online) NIAID Communication with Mexico’s Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) (August-September 2024) (MEX-109)

(Document) Regulatory System Strengthening in the Americas: Lessons Learned from the National Regulatory Authorities of Regional Reference (MEX-110) (2022)
Pan American Health Organization (PAHO), World Health Organization

(Webpage) COFEPRIS Electronic Procedures Portal (MEX-103 - Spanish) (Current as of November 8, 2024)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) DIGIPRiS Manuals: Self-management Procedures (MEX-106 - Spanish) (October 16, 2022)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) DIGIPRiS: Online Regulation (MEX-86 - Spanish) (Current as of November 8, 2024)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) DIGIPRiS Research and Clinical Trials (MEX-104 - Spanish) (December 1, 2023)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) Get your e.signature (e.firma) Certificate (MEX-105 - Spanish) (Current as of November 8, 2024)
Tax Administration Service (SAT)

(Webpage) ICH Members & Observers (MEX-41) (Current as of November 8, 2024)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(Webpage) List of PIC/S Participating Authorities - Mexico (MEX-111) (Current as of November 8, 2024)
Pharmaceutical Inspection Co-operation Scheme (PIC/S)

(Webpage) Mexican Foreign Trade Single Window (VUCEM) (MEX-114 - Spanish) (Current as of November 8, 2024)
General Customs Administration

(Webpage) VigiRam (MEX-118 - Spanish) (Current as of November 8, 2024)
Uppsala Monitoring Centre, World Health Organization

Sources Revised During this Update:

(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 February 7, 2024)
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 February 7, 2024)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Regulation) Regulation of Health Products (Reg-HlthProd - Spanish) (English-Reg-HlthProd – Google Translation) (Last Updated May 31, 2021)
Ministry of Health

(Guidance) Request for Authorization of Research Protocols in Human Beings Modality D: Risk-Free Research (Observational Studies) (COFEPRIS-04-010-D) (G-ObsrvStdies - Spanish) (Last Updated February 22, 2024)
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, 2024 (MEX-11 - Spanish) (English-MEX-11 – Google Translation) (December 29, 2023)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Document) Data Protection Laws and Regulations Mexico 2024 (MEX-4) (July 31, 2024)
Olivares, Abraham Diaz Arceo and Olivares, Giustavo Alcocer; ICLG

(Form) Example of Installation Record of the Research Ethics Committee (MEX-27 - Spanish) (English-MEX-27 – Google Translation) (December 11, 2019)
National Bioethics Commission (CONBIOÉTICA), Ministry of Health

(Webpage) COFEPRIS - National Registry of Clinical Trials (RNEC) (MEX-68 - Spanish) (v2.0) (Current as of November 8, 2024)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health