China’s Clinical Trials & Related Quality Rules and Regulations Updated

China’s Clinical Trials & Related Quality Rules and Regulations Updated

China’s food and drug regulators continue to change compliance requirements as the world’s second-largest economy continues to attempt to streamline and modernize its regulatory scheme. China seeks to attract more clinical trials to the mainland as it seeks to advance its biomedical sector—a space given high priority by the national government. One of TrialSite’s favorite websites, the National Institute of Allergy and Infectious Diseases (NIAID) ClinRegs website, was recently updated with information regarding China.

ClinRegs reports that Chinese regulators have added a new personal information protection law to ensure better safety of the personal information associated with clinical trials. These changes can be reviewed in the Definition of Sponsor, Quality, and Data & Records Management. 

Moreover, new regulations were promulgated involving the process and the materials associated with a request for a pre-application meeting with the Center for Drug Evaluation. Additionally, ClinReg updated information associated with the Ethics Committee, Clinical Trials Lifecycle, and Informed consent—all important topics for any clinical research in C...

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