China Updates
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) ...
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 ...
China Profile Updated to Include New NMPA Guidelines
Apr 6, 2023 - The China profile in ClinRegs has been updated to include the following guidelines issued by the National Medical Products Administration (NMPA) in March 2023:
New guidance regarding the Phase III pre-clinical trial meeting with the Center for Drug Evaluation when ...
China Profile Updated
Nov 18, 2022 - The China profile in ClinRegs has been reviewed and updated with the following information:
New guidelines for protocol changes during drug clinical trials (See Scope of Review, Submission Process, and Risk & Quality Management)
Several new quality management and technical guidelines ...
China Profile Updated in ClinRegs
Oct 28, 2021 - The China profile in ClinRegs has been reviewed and updated with the following information:
New Personal Information Protection Law to ensure the safety of the personal information processed during clinical trials (See Definition of Sponsor and Quality, Data & Records ...
China Profile Updated with New Biosecurity Law
Feb 17, 2021 - The China profile in ClinRegs has been updated to include China’s Biosecurity Law, which was enacted in October 2020 and goes into effect on April 15, 2021. The law governs several biosecurity areas, including the collection and management of human genetic resources ...
China Profile Updated in ClinRegs
Oct 30, 2020 - The China profile in ClinRegs now includes the following updates:
Updated contact information for the regulatory authorities (See Regulatory Authority)
New online platforms for submitting clinical trial materials (See Regulatory Authority and Submission ...
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