Updates | ClinRegs

Bangladesh Profile Updated with Nagoya Protocol Party Information

Jan 12, 2024 - The Bangladesh profile in ClinRegs has been updated to reflect that Bangladesh is party to the Nagoya Protocol on Access and Benefit-sharing. (See Regulatory Authority and Manufacturing & Import)Sources Added During this Update: (Document) Nagoya Protocol on Access and Benefit-sharing ...

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 ...