Updates
US Profile Updated
Jan 5, 2024 - The United States profile in ClinRegs has been reviewed and updated with the following information:Updated Food & Drug Administration (FDA) guidance on informed consent (See Risk & Quality Management and the Informed Consent topic)Information on the Food and Drug Omnibus Reform Act ...
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 ...
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