Peru Profile Updated with Amended Clinical Trial Authorization Procedures
The Peru profile in ClinRegs has been updated to include the Headquarters Resolution No. 252-2022-J-OPE/INS, which modifies the clinical trial authorization procedures (section 7.5) in the Manual of Clinical Trials Procedures (MAN-INS-001).
Clinical trial applications and accompanying documentation must now be submitted electronically via the Virtual Submission Platform (Mesa de Partes Virtual (MPV)). (See Scope of Assessment and Submission Process)
Sources Added During this Update:
(Regulation) Headquarters Resolution No. 252-2022-J-OPE/INS – Approves the Amendment to the Clinical Trial Authorization Procedure in the Manual of Clinical Trials Procedures (MAN-INS-001) (Res252-2022 - Spanish) (November 25, 2022)
National Institute of Health, Ministry of Health
(Document) Headquarters Resolution No. 252-2022-J-OPE/INS – Annex 1: Clinical Trial Authorization Process Flowchart (PER-6 - Spanish) (November 25, 2022)
National Institute of Health, Ministry of Health