Peru Profile Updated

December 21, 2022
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The Peru profile in ClinRegs has been reviewed for accuracy and updated with the following information:

  • Regulations and resources on personal data protection and treatment of health-related personal data (See Personal Data Protection)
  • New INS virtual submission platform and related resources (See Submission Process)
  • Guideline on INS inspection fines assessment and Clinical Trial Inspection Sheet form (See Risk & Quality Management)
  • Guidance on registration procedures for ethics committees conducting human health research (See Oversight of Ethics Committees)
  • INS guideline on management of clinical trial safety reporting (See Safety Reporting)
  • INS guidelines on good storage practices and good dispensing practices for pharmaceutical products now available (See Product Management)

Sources Added During this Update:

(Legislation) Law No. 27806 - Law on Transparency and Access to Public Information (Law27806 - Spanish) (Effective December 11, 2019)
Congress of the Republic

(Guidance) Manual of Good Dispensing Practices (G-GDPs - Spanish) (January 15, 2009)
Ministry of Health

(Guidance) Methodological Guide for Grading Fines for Non-Compliance with the Clinical Trials Regulation (G-CTFines - Spanish) (August 12, 2021)
National Institute of Health, Ministry of Health

(Guidance) Procedure for the Management of Safety Information in Authorized Clinical Trials (G-CTSafety - Spanish) (Edition No. 1) (January 11, 2021)
National Institute of Health, Ministry of Health

(Guidance) Procedure for the Use of the Virtual Submission Platform at the National Institute of Health (G-VirtSubPlatfrm - Spanish) (Edition No. 02) (June 14, 2022)
National Institute of Health, Ministry of Health

(Guidance) Registration Procedure for Research Ethics Committees (CEI) for Health Research with Human Beings (G-ECRegProcs - Spanish) (Edition No. 1) (July 26, 2021)
National Institute of Health, Ministry of Health

(Guidance) Technical Document: Manual of Good Storage Practices for Pharmaceutical Products, Medical Devices and Health Products in Laboratories, Drugstores, Specialized Warehouses and Customs Warehouses (G-GSPs - Spanish) (March 2, 2015)
Ministry of Health

(Guidance) Virtual Submission Platform - User Manual (G-MPVManual - Spanish) (May 5, 2022)
General Office of Information and Systems, National Institute of Health, Ministry of Health

(Regulation) Administrative Directive No. 294-MINSA/2020/OGTI - Establishing the Treatment of Personal Data Related to Health or Personal Data in Health (RegDir294-2020 - Spanish) (September 1, 2020)
Ministry of Health

(Regulation) Ministerial Resolution No. 688-2020/MINSA - Administrative Directive Establishing the Treatment of Personal Data Related to Health or Personal Data in Health (Res688-2020 – Spanish) (September 1, 2020)
Ministry of Health

(Regulation) Regulation of Legislative Decree No. 1353 – Legislative Decree Creating the National Authority for Transparency and Access to Public Information, Strengthens the Personal Data Protection Regime and the Regulation of Interest Management (Issued by Supreme Decree 019-2017-JUS) (RegLaw1353 - Spanish) (September 15, 2017)
Minister of Justice and Human Rights

(Article) Administrative Directive Approved for the Treatment of Personal Data Related to Health in Peru (PER-99 - Spanish) (January 13, 2021)
Escobedo, Catherine; IAPP

(Article) Ministry of Health approves Directive that Establishes the Treatment of Personal Data Related to Health or Personal Health Data (PER-101 - Spanish) (September 2020)
Benites, Vargaz & Ugaz

(Article) National Institute of Health Inaugurated Virtual Submission Platform and Electronic Notification (PER-104 - Spanish) (April 25, 2022)
National Institute of Health

(Article) The INS goes Hand in Hand with Technology and Promotes the Procedure for the Use of its Virtual Submission Platform (MPV) (PER-105 - Spanish) (June 23, 2022)
National Institute of Health

(Document) Communique No. 008-2022-OGITT/INS - Framework for the Implementation of the Virtual Submission Platform (MPV) System (PER-110 - Spanish) (April 29, 2022)
General Office for Research and Technology Transfer, National Institute of Health

(Document) Communique No. 009-2022-OGITT/INS - Implementation of the Virtual Submission Platform (MPV) System (PER-103 - Spanish) (July 7, 2022)
General Office for Research and Technology Transfer, National Institute of Health

(Document) Terms and Conditions for the Use of the Virtual Submission Platform (MVP-INS) (PER-107 - Spanish) (March 22, 2022)
National Institute of Health

(Form) Inspection Sheet for a Clinical Trial (FOR-OGITT-049) (PER-100 - Spanish) (Edition No. 02) (March 30, 2022)
National Institute of Health, Ministry of Health

(Webpage) Characteristics of REPEC (PER-111 - Spanish) (Current as of December 20, 2022)
REPEC, National Institute of Health, Ministry of Health

(Webpage) DIGEMID - Institutional Information (PER-108 - Spanish) (Current as of December 20, 2022)
Ministry of Health

(Webpage) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (PER-109 - Spanish) (Current as of November 20, 2022)
Ministry of Health

(Webpage) Registration of Institutional Research Ethics Committee (PER-102) (Current as of December 20, 2022)
REPEC, National Institute of Health, Ministry of Health

(Webpage) Virtual Submission Platform (PER-106 - Spanish) (Current as of November 2, 2022)
National Institute of Health

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