NMPA Clinical Trial Audit
In 2019, the NMPA audited the clinical trials of two batches of medical devices for registration.
This random audit revealed that human CYP2D6 * 10, CYP2C9 * 3, ADRB1 (1165G> C), AGTR1 (1166A> C), CYP3A5 * 3, NPPA (T2238C), ACE (I) gene detection kit (PCR-melting curve method) (Acceptance No. CSZ1900142) produced by Inner Mongolia Tailing Jinzhun Gene Technology Co., Ltd was used in a clinical trial conducted by the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, and no trace record of the clinical trial was found in the operating system of the quantitative PCR instrument (the test operation equipment); The recorded testing time of clinical test sample partially overlaps with other samples. The data of clinical trials cannot be traced and there are problems of authenticity.
According to Chinese regulations, the above product will not get approval and NMPA will not accept the registration application of this product again within one year.
Clinical trial in China should be conducted as per China GCP Regulation. If there is any authenticity issue, the product will be rejected by NMPA and the company will be into the black list of NMPA.
Bradynuoen has helped one of our cardiovascular clients based in US to pass the audit of clinical trial from NMPA in Dec, 2019. Please do not hesitate to contact us for any questions about your clinical affairs via info@inspirativemed.com.
