Grace Palma, CEO of China Med Device, is invited to talk on Precision Medicine Panel of CABA (Chinese-American BioMedical Association) meeting in Boston.
Grace will focus on IVD/CDx regulatory and clinical affairs roles in China.
Over last years, NMPA has prepared regulatory establishments for IVD & CDx and granted a number of approvals. The Fourth Batch of Clinical Trial Exemptions, published in September 2019, exempted 31Class III IVD reagents for the first time which are cancer-related biomarkers. After the fifth draft batch implemented, a total of 420 IVDs will be exempted from clinical trials in China since the first exemptions catalog in 2014.
NMPA published draft IVD Clinical Trial Guideline for feedback on November 22nd, 2018. It states 11 majot policy changes concerning clinical sites, sample size, the qualification and quantification of clinical data, etc.
Precison Medicine side, NMPA approved the ‘human 10 gene mutation combined detection kit’, manufactured by Amoy Diagnostics, on November 20, 2018. The kit is intended for the detection of ten gene mutations for patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC): EGFR, ALK, ROS1, RET, KRAS, NRAS, PIK3CA, BRAF, HER2, and MET. It can assist in the diagnosis to determine the benefits from anti-cancer drugs including Gefitinib, Oxitinib, Kezotinib, Cetuximab, etc. It is the the fifth approval of Next-Generation Sequencing (NGS) and the first multiple biomarker-based GNS granted by NMPA.
For our comments on Clinical Trial Exemptions, please click HERE.
For IVD Clinical Guideline, please click HERE.
For news about gene mutation combined detection kit, please click HERE.
At the influential CABA event, prominent entrepreneurs, investors, biotech and pharma executives, academic and industry scientists, as well as professionals from the legal, finance, and healthcare fields will be join together to discuss China. Industry leaders include:
About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.