Peru Profile Updated

April 24, 2024
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The Peru profile in ClinRegs has been reviewed and updated with the following information:

  • Legislative decree from 2018 modifying Peru’s research center registration certificate requirements (See Timeline of Review)
  • October 2023 National Institute of Health (Instituto Nacional de Salud (INS)) regulations on amendments and minor changes in the protocol and/or informed consent form and related criteria (See Regulatory Authority, Scope of Assessment, Scope of Review, and Timeline of Review)
  • June 2023 resolution integrating the regulations on the INS’s organization and functions (See Regulatory Authority)
  • 2023 INS communications regarding the transition from the REPECv1 platform to the REPECv2 platform for report submissions (See Submission Process and Progress Reporting)
  • November 2023 INS communication notifying users of the indefinite validity of the research center registration certificate (See Site/Investigator Selection)
  • INS webpages for the Directorate of Health Research and Innovation and its Clinical Trials and Health Research subdirectorates (See Regulatory Authority)
  • Details on clinical trial application fee payment instructions (See Regulatory Fees)

Sources Added During this Update:

(Legislation) Legislative Decree No. 1452 - Modifies the Law No. 27444, General Administrative Procedure Law (Law1452 - Spanish) (English-Law1452 - Google Translation) (September 16, 2018)
Congress of the Republic

(Regulation) Directorial Resolution No. 184-2023-DIIS/INS – Approval of the List of Exhaustive and Non-Substantial Assumptions that are Considered Minor Changes to the Protocol and/or Informed Consent (Res184-2023 - Spanish) (October 27, 2023)
National Institute of Health, Ministry of Health

(Regulation) Executive Presidency Resolution No. 006-2023-PE/INS – Approval of the Integrated Text of the Regulations on the Organization and Functions of the National Institute of Health (INS) (Res006-2023 - Spanish) (June 22, 2023)
National Institute of Health, Ministry of Health

(Regulation) Supreme Decree No. 023-2023-SA - Decree that Modifies and Incorporates Various Articles in the Clinical Trials Regulation, Approved by Supreme Decree No. 021-2017-SA (Decree028-2023 - Spanish) (English-Decree028-2023 - Google Translation) (October 18, 2023)
National Institute of Health, Ministry of Health

(Document) Communique No. 002-2023-OGITT/INS - Migration of Information from the REPECv1 System to REPECv2 (PER-114 - Spanish) (May 19, 2023)
General Office for Research and Technology Transfer, National Institute of Health

(Document) Communique No. 004-2023-DIIS/INS - Validity of the Research Center Registration Certificate (PER-113 - Spanish) (English-PER-113 - Google Translation) (November 8, 2023)
General Office for Research and Technology Transfer, National Institute of Health

(Document) Communique No. 006-2023-DIIS/INS - REPECv1 Closure Notification and REPECv2 Report Submission Requirement (PER-92 - Spanish) (English-PER-92 - Google Translation) (December 15, 2023)
Directorate of Health Research and Innovation, National Institute of Health

(Webpage) Clinical Trials Subdirectorate – Description (PER-56 - Spanish) (Last Updated March 21, 2024)
National Institute of Health, Ministry of Health

(Webpage) Directorate of Health Research and Innovation (DIIS) – Description (PER-20 - Spanish) (Last Updated January 14, 2024)
National Institute of Health, Ministry of Health

(Webpage) Electronic Forms Available in the Peruvian Registry of Clinical Trials (REPEC) (PER-112 - Spanish) (Current as of April 19, 2024)
REPEC, National Institute of Health, Ministry of Health

(Webpage) Functions of the Directorate of Health Research and Innovation (DIIS) (PER-55 - Spanish) (Last Updated December 18, 2023)
National Institute of Health, Ministry of Health

(Webpage) Health Research Subdirectorate – Description (PER-68 - Spanish) (Last Updated January 14, 2024)
National Institute of Health, Ministry of Health

Sources Revised During this Update:

(Not Available Online) NIAID Communication with Peru’s National Institute of Health (October-November 2023 and April 2024) (PER-77)

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