The China Clinical Trials GCP (Good Clinical Practice) 2022 amended version will come into effect on May 1, 2022.
Running, or planning, clinical trials in China for medical device or IVD?
In March 2022, the National Medical Products Administration (NMPA) and National Health Commission (NHC) have released important updated clinical practice requirements for clinical trials in China for medical device and IVD:
- Good Clinical Practice for Medical Devices (Decree No.28)
- Matters related to the implementation of the good management practice for clinical trials of medical devices (No.21-2022)
China Clinical Trials GCP – Key Changes
Manufacturers, sponsors and others running or planning clinical trials should be aware about the following key changes to the regulation framework for their China clinical trials:
- The adjustment structure has been clarified and emphasizes the responsibilities of all parties:
- Highlight the main responsibility of the sponsor, introduce the concept of risk management, and clearly stipulate that the quality management system of the sponsor should cover the whole process of clinical trials of medical devices;
- Strengthen the requirements of clinical trial institutions for medical devices, clinical trial institutions should establish a clinical trial management organizational structure and management system;
- Emphasize the responsibilities of researchers, and researchers should implement clinical trials of medical devices in accordance with the provisions of the Code and relevant laws and regulations.
- Key documentation guidance for clinical trial reports, adverse event reports and basic documentation have been updated and clarified.
- In order to facilitate smooth implementation of clinical trials, the 1-year validity of test reports no longer exists.
- Reporting safety information to the respective MPA and health management departments no longer need to be submitted as a “dual report” by the sponsor and investigator, but instead, a “single report” by the sponsor will suffice.
Manufacturers, sponsors, CROs and others involved in clinical trials in China should study the new guideline closely.
By Hamish King and Jacky Li. Cisema regularly support clinical trials in China as a CRO. For our clinical trial protocol and preparatory studies, or more details about full support in accordance with the China clinical trials GCP, please inform us.