Feedback Needed for CDx Guideline by China NMPA

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Feedback Needed for CDx Guideline by China NMPA

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China’s Center for Medical Device Evaluation (CMDE), a division of NMPA announced its preparation of “Technical Review Guideline of Clinical Trial for Co-development of CDx Reagents and Anti-tumor Drugs” on June 3rd, 2020. CMDE is collecting the CDx manufacturer’s information. Whether you are an IVD or drug/pharmaceutical manufacturer in or outside of China, you have an opportunity to have your companion diagnostic needs for the clinical trial heard in the co-development of CDx reagents and anti-tumor drugs.

This notice is not only intended for the manufactures with the CDx reagents already approved by NMPA, but also for the companies which plan to enter the CDx market. Domestic and overseas manufactures are all welcome to fill the information collection form. You can email info@ChinaMedDevice.com for the form or (see link). Do not miss your chance to provide your opinions and comments about the guideline during the NMPA preparation phase.

The submission deadline is June 30, 2020. For more information about how this process work, please contact China Med Device (Email: info@chinameddevice.com).  We can also help you prepare and submit the feedback directly.

China CDx Regulatory Background and our Resources

Despite the fast-growing market for CDx products, China has no published CDx-specific guidelines and there is no clear definition about CDx related products. Most of the related products have been registered under Class III medical devices and approved based on currently available regulations for medical devices and IVDs.

With the rapid development of CDx and next-generation sequencing (NGS) products, NMPA published several technical review guidelines to aid the development and registration process for certain types of CDx related products (NO. 2 and NO.3 in table 1). Being aware of the regulatory review process and CDx guidance of the FDA and considering the local medical environment, NMPA is developing an adaptive regulatory approach to guide the development and registration of CDx products in China. The plan for the new guideline on clinical trial is also one of many efforts of NMPA to guide manufacturers to get their cancer therapeutic products to China market faster. Cancer is one of the top three killers in China along with cardiovascular and diabetes diseases.

Table 1. NMPA CDx-Related Guidelines

NO.GuidelinePublish date
1Technical review guideline for genetic mutation detection reagents related to personalized cancer treatmentMar. 2014
2Human epidermal growth factor receptor (EGFR) mutant gene detection reagents technical review guideline (PCR method)Feb. 2018
3Registration technical review general guideline for performance evaluation of the reagents used for tumor related genetic mutation test (high-throughput sequencing)Dec. 2019
4Technical review guideline and IFU update for CDx based on the same type of tumor medicinesIn preparation
5Technical review guideline of clinical trial for co-development of CDx reagents and anti-tumor drugsIn preparation

China Med Device has the leading position in CDx consulting services in China. We have worked with many oversea clients to help them expand their CDx business in China, from preparing regulatory strategies, to providing post-market services and working with global regulatory agencies to achieve their marketing objectives. We have the following additional documents that can help both IVD and drug manufacturers to understand China CDx regulatory and clinical affairs landscape better.

Other CMD Resources

  • White paper “Overview of Companion Diagnostics Products in China.”
  • Actual approved relevant cases in-depth review by NMPA.
ProductsPublication date
Human EGFR / KRAS / BRAF / HER2 / ALK / ROS1 gene mutation detection kit (semiconductor sequencing)2020-02-07
PD-L1 test kit (Immunohistochemistry)2019-12-17
PD-L1 test kit (Immunohistochemistry)2019-09-02
Human 10 gene mutation combined detection kit (reversible terminator sequencing)2018-11-21
EGFR/ALK/ROS1/BRAF/KRAS/HER2 gene mutation detection kit (reversible terminator sequencing) 2018-09-30
Human EGFR, KRAS, BRAF, PIK3CA, ALK, ROS1 gene mutation detection kit (semiconductor sequencing 2018-08-15
Human EGFR/ALK/BRAF/KRAS gene mutation combined detection kit (reversible terminator sequencing) 2018-07-26
Human EGFR gene mutation detection kit (multi-fluorescence PCR) 2018-01-25
  • CDx registration requirements, PPTs presented by NMPA senior reviewer in 2019 (Registration Application Requirements for CDx, Feb 2019 and CDx Registration Requirements and General Questions, July 2019).

Please email info@chinameddevice.com to request a copy of these documents. Certain documents incur translation fee charges.

About ChinaMed Device, LLC 

China Med 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.