Updates | ClinRegs

China Profile Updated with Minors Protection Law

Jan 16, 2024 - The China profile in ClinRegs has been updated to include the Minors Protection Law of the People's Republic of China, which took effect on June 1, 2021. The Law defines minors as citizens who are under the age of 18. (See Children/Minors) Sources Added During this Update:(Legislation) ...

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 ...

Australia Profile Updated with Revised TGA Contact Information

Jan 12, 2024 - The Australia profile in ClinRegs has been updated to include a revised general enquiries email for the Therapeutic Goods Administration (TGA). (See Regulatory Authority)Sources Added During this Update: (Webpage) Get in Touch with Us (AUS-11) (Current as of January 12, 2024)Therapeutic ...

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 ...