Updates | ClinRegs

South Africa Profile Updated

Dec 18, 2023 - The South Africa profile in ClinRegs has been reviewed and updated with the following information:New requirements related to clinical trial application rejection, submission documents, and investigational product (IP) quality information from the South Africa Health Products Regulatory Authority’s ...

Peru Profile Updated with Revised OGITT Address

Dec 5, 2023 - The Peru profile in ClinRegs has been updated to include a revised address for the General Office for Research and Technology Transfer (OGITT) (See Regulatory Authority).Sources Added During this Update: (Document) Communique No. 001-2023-OGITT/INS – New OGITT Address (PER-13 - Spanish) ...

China Profile Updated

Nov 30, 2023 - The China profile in ClinRegs has been reviewed and updated with the following information:New address and contact information for the National Medical Products Administration’s (NMPA’s) Center for Drug Evaluation (CDE) (See Regulatory Authority)NMPA handling guidelines on the registration ...

Sierra Leone Profile Updated

Nov 1, 2023 - Sierra Leone Profile Updated The Sierra Leone profile in ClinRegs has been reviewed and updated with the following information: Additional contact information for the Pharmacy Board of Sierra Leone (PBSL) (See Regulatory Authority) Updated list of documents to be submitted to the ...

Mexico Profile Updated with Revised Ethics Committee Registration Form and Air Transport Info for Imports

Oct 18, 2023 - The Mexico profile in ClinRegs has been updated with the following information: New version of the National Bioethics Commission (CONBIOETICA)’s Research Ethics Committee (REC) Registration Form and the corresponding tutorial for submitting a REC registration ...

Tanzania Profile Updated with Clarified Records Retention Requirements

Oct 16, 2023 - The Tanzania profile in ClinRegs has been updated to clarify records retention requirements related to the following: National Health Research Ethics Committee (NatHREC) records for prematurely terminated studies (see Ethics Committee) Sponsor and investigator retention ...

Vietnam Profile Updated with Personal Data Protection Decree

Sep 28, 2023 - The Vietnam profile in ClinRegs has been updated to include Decree No. 13/2023/ND-CP – Protection of Personal Data, which took effect on July 1, 2023. The Decree regulates the protection of personal data and the personal data protection responsibilities of relevant agencies, organizations, ...