Peru Profile Updated
The Peru profile in ClinRegs has been reviewed and updated with the following information:
- 2024 National Institute of Health (Instituto Nacional de Salud (INS)) resolution approving the updated Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud (DIIS))’s clinical trial administrative procedure forms added throughout the profile
- 2025 INS regulation approving the consolidated text of administrative procedures (TUPA), which includes details on clinical trial authorization fees, ethics committee accreditation, and timelines and processes related to a variety of procedures (See Regulatory Fees, Ethics Committee Fees, Oversight of Ethics Committee, Timeline of Review, Site/Investigator Selection, and Risk & Quality Management)
- 2024 INS guidance providing clinical study report format requirements (See Progress Reporting)
- Personal data protection regulation and related resources, which took effect in March 2025 (See Personal Data Protection)
- 2024 INS document regarding modification/extension of list of clinical trial products and supplies (See Manufacturing & Import)
- Additional details on the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM)) (see Regulatory Authority)
- Additional references to INS resources related to clinical trial submissions added throughout the profile where appropriate
Please note: The Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) websites (https://ensayosclinicos-repec.ins.gob.pe and https://repec.ins.gob.pe) and ClinRegs sources directly linked to these sites are not accessible to users outside of Peru.
Sources Added During this Update:
(Legislation) Law No. 29459 - Law on Pharmaceutical Products, Medical Devices and Health Products (Law29459 - Spanish) (Effective November 25, 2009)
Congress of the Republic
(Regulation) Directorial Resolution No. 085-2025-DIIS/INS (Res085-2025 - Spanish) (February 13, 2025)
National Institute of Health, Ministry of Health
(Regulation) Directorial Resolution No. 090-2025-DIIS/INS (Res090-2025 - Spanish) (February 20, 2025)
National Institute of Health, Ministry of Health
(Regulation) Directorial Resolution No. 435-2024-DIIS/INS (Res435-2024 - Spanish) (English-Res435-2024 – Google Translation) (October 15, 2024)
National Institute of Health, Ministry of Health
(Regulation) Ministerial Resolution No. 833-2024-MINSA (Res833-2024 - Spanish) (Effective August 21, 2025)
National Institute of Health, Ministry of Health
(Regulation) Supreme Decree No. 016-2024-JUS - Approves the Regulation of Law 29733, Personal Data Protection Law (Decree016-2024 - Spanish) (English-Decree016-2024 – Google Translation) (Effective March 30, 2025)
National Institute of Health, Ministry of Health
(Guidance) Annex 02: Guide for Reporting Clinical Trial Results and Conclusions (G-CTReptReslts - Spanish) (March 14, 2024)
National Institute of Health, Ministry of Health
(Article) Peru Publishes New Personal Data Protection Regulations (PER-122 - Spanish) (January 8, 2025)
Escobedo, Catherine; IAPP
(Article) The Designation of the Data Protection Officer: The Case of Peru (PER-121) (March 7, 2025)
Hernandez, Sabrina; Baker McKenzie
(Regulation) Supreme Decree No. 010-2025-SA - Approves the Consolidated Text of Administrative Procedures (TUPA) of the National Institute of Health (INS) (Decree010-2025 - Spanish) (English-Decree010-2025 – Google Translation) (July 2, 2025)
National Institute of Health, Ministry of Health
(Document) List of Products and Supplies to Import in the Clinical Trial – Annex 01 and Annex 02 (FOR-DIIS-033) (PER-116 - Spanish) (English-PER-116 – Google Translation) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Request to Expand or Modify the List of Supplies (FOR-DIIS-033) (PER-117 - Spanish) (English-PER-117 - Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(International Guidance) ICH Harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports (E3) (PER-124) (Step 4 version) (November 30, 1995)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(Webpage) Access the Virtual Submission Platform (MPV) (PER-124 - Spanish) (Last Updated February 7, 2025)
National Institute of Health
(Webpage) Clinical Trial Forms (PER-123 - Spanish) (Current as of August 13, 2025)
National Institute of Health
(Webpage) Clinical Trials (PER-125 - Spanish) (Current as of August 13, 2025)
National Institute of Health
(Webpage) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (PER-119 - Spanish) (Last Updated January 14, 2024)
National Institute of Health
(Webpage) Peruvian Registry of Clinical Trials (REPEC): Frequently Asked Questions (PER-120 - Spanish) (Last Updated February 12, 2025)
National Institute of Health
(Webpage) Register an Institutional Research Ethics Committee (CIEI) (PER-126 - Spanish) (Last Updated September 7, 2023)
National Institute of Health
(Webpage) Request Authorization to Conduct a Clinical Trial (PER-115 - Spanish) (Last Updated December 10, 2024)
National Institute of Health
(Webpage) Request a Modification of the Clinical Trial Authorization Conditions (PER-118 - Spanish) (Last Updated February 14, 2025)
National Institute of Health
Sources Revised During this Update:
(Form) Affidavit of Absence of Financial Conflict of Interest (FOR-DIIS-063) (PER-34 - Spanish) (English-PER-34 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Affidavit of Compliance with Minimum Research Center Requirements (FOR-DIIS-023) (PER-44- Spanish) (English-PER-44 – Google Translation) (Edition No. 01) (October 10, 2024)
National Institute of Health, Ministry of Health
(Form) Affidavit of Compliance with the Accreditation Standards of the Institutional Research Ethics Committee (CIEI) (FOR-DIIS-026) (PER-21 - Spanish) (English-PER-21 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Affidavit of Research Center Preparedness for Clinical Trial (FOR-DIIS-064) (PER-35 - Spanish) (English-PER-35 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Application for Accreditation of the Institutional Research Ethics Committee (FOR-DIIS-025) (PER-85 - Spanish) (English-PER-85 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Application for Authorization of Clinical Trial Amendment Report (FOR-DIIS-044) (PER-33 - Spanish) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Application for Clinical Trial Authorization (FOR-DIIS-028) (PER-24 - Spanish) (Edition No. 03) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Application for Closure of Clinical Trial Research Center (FOR-DIIS-040) (PER-43 - Spanish) (English-PER-43 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Application for Contract Research Organization Registration (FOR-DIIS-021) (PER-37 - Spanish) (English-PER-37 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Application for Expansion of the Number of Research Centers (FOR-DIIS-036) (PER-26 - Spanish) (English-PER-26 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Application for Principal Investigator Change (FOR-DIIS-038) (PER-28 - Spanish) (English-PER-28 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Application for Sponsor Registration (FOR-DIIS-020) (PER-36 - Spanish) (English-PER-36 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Clinical Trial Results Report to be Published in REPEC (FOR-DIIS-058) (PER-23 - Spanish) (English-PER-23 - Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Curriculum Vitae of the Research Team (FOR-DIIS-031) (PER-50 - Spanish) (English-PER-50 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Detailed Total Clinical Trial National Budget (FOR-DIIS-032) (PER-25 - Spanish) (English-PER-25 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Inspection Sheet for a Clinical Trial (FOR-DIIS-049) (PER-100 - Spanish) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) List of Products and Supplies to be Used in the Clinical Trial (FOR-DIIS-033) (PER-42 - Spanish) (English-PER-42 - Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Notification of Deviations to the Protocol (FOR-DIIS-053) (PER-40 - Spanish) (English-PER-40 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Notification of Pregnant Woman and Newborn in Clinical Trials (FOR-DIIS-047) (PER-39 - Spanish) (Edition No. 01) (October 15, 2025)
National Institute of Health, Ministry of Health
(Form) Other Relevant Notifications (FOR-DIIS-059) (PER-41 - Spanish) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Request for Clinical Trial Cancellation (FOR-DIIS-042) (PER-31 - Spanish) (English-PER-31 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Request for Clinical Trial Suspension (FOR-DIIS-041) (PER-30 - Spanish) (English-PER-30 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Request for Extension of Clinical Trials Conduct Time (FOR-DIIS-037) (PER-27 - Spanish) (English-PER-27 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Request for Sponsor or Contract Research Organization Change (FOR-DIIS-039) (PER-29 - Spanish) (English-PER-29 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Serious Adverse Event Report (FOR-DIIS-046) (PER-38 - Spanish) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Sponsor Affidavit for Sufficient Financial Funds (FOR-DIIS-029) (PER-51 - Spanish) (English-PER-51 – Google Translation) (Edition No. 01) (October 15, 2024)
National Institute of Health, Ministry of Health
(Form) Summary of the Annual Investigational Product Safety Report (FOR-DIIS-048) (PER-45 - Spanish) (Edition No. 01) (October 15, 2025)
National Institute of Health, Ministry of Health
(Form) Verification of Compliance with the Accreditation Standards of the Institutional Ethics Committees (CIEIs) (FOR-DIIS-027) (PER-22 - Spanish) (Edition No. 1) (October 15, 2024)
National Institute of Health, Ministry of Health