On March 31, 2022, NMPA officially released China new GCP (Medical Device Clinical Trial Quality Management Provisions, i.e., Medical Device Good Clinical Practice). The new GCP will take effective since May 1, 2022.
Key points in China new GCP are listed as below:
Reorganize the framework of GCP
Clarify the responsibilities of each party involved in clinical trial
Sponsor is a major role in clinical trial, including risk management into clinical trial
Enhance the requirement of clinical trial site
Enhance the responsibility of investigators
IVD clinical trial regulated by GCP similar as medical device
Adjust the safety information reporting process (SAE reporting)
Simplify and optimize some requirement
Delete the requirement of Medical device clinical trial shall be conducted in two and above clinical trial institutions, solving the issue of some medical devices difficult and not necessary to conduct clinical trial in two sites.
Delete the requirement on test report with 1-year validity (one important dossier for IRB/EC application), beneficial to clinical trial.
Reflect the requirement of latest international regulatory system (IMDRF MDCE WG/N57 FINAL:2019)
Introducing the concept of conducting multi-region clinical trial in different countries or regions
Beneficial to global innovative device conducting medical device clinical trial in China in parallel
Since May 1, 2022, if the clinical trials have not received IRB/EC approval, such projects should conduct as per new GCP. If the clinical trials have received IRB/EC approval, such projects can conduct as per old requirement.
In order to guide the conduction of clinical trial, NMPA has formulated another six documents with this new GCP, including Medical Device Clinical Trial Protocol Template, Medical Device Clinical Trial Report Template, IVD Clinical Trial Protocol Template, IVD Clinical Trial Report Template, Medical Device/IVD Clinical Trial SAE Report Template and Medical Device/IVD Clinical Trial Basic Document Catalogue.
Although new amendments in GCP are conductive to clinical trial in China, the requirements of clinical trial following GCP have always been enhanced. The least burdensome clinical approach is the most critical issue for China entry plan related to cost and time.
Brady knows the least burdensome clinical approach whether you are making clinical strategic plans, launching pre-market or post-market clinical trials, writing a CER to meet country-specific requirements, or collecting real-world data to support your submission. Reach out to BradyKnows for the least burdensome clinical approach via info@bradyknowsmedical.com
