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NMPA Officially Published Five IVD/CDx Related Guidelines


The NMPA officially published the first guideline specifically for CDx reagents, the “Guideline for Technical Review and IFU Update for Oncology CDx Based on the Same Group of Therapeutic Drugs” on April 7, 2021. On the same day NMPA also published 4 other guidelines to guide the registration of different types of IVD reagents including rotavirus antigen test, group B Streptococcus nucleic acid test, Human Parvovirus B19 IgM/IgG antibody test, and one platform, real-time fluorescent PCR machine.

The “Guideline for Technical Review and IFU Update for Oncology CDx Based on the Same Group of Therapeutic Drugs” aims to guide the document preparation for the IFU update of CDx for a specific group or class of oncology therapeutic products. Here, the “Same Group of Therapeutic Drugs” refer to at least two NMPA approved oncology therapeutic drugs with the same mechanism of actions, same biomarkers, and the same applicable population. Based on the NMPA requirements, the applicants need to apply for the change of permission items for IFU updates of IVD reagents.

For “Guideline for Performance Evaluation of the Reagents Used for Tumor Related Genetic Mutation Test (high-throughput sequencing)”, please click HERE.

For “Draft Guideline of Clinical Trial for Co-development of CDx Reagents and Anti-tumor Drugs”, please click HERE.

To keep up with the international standard, it refers to FDA guidance of “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products” published in April 2020, and “In Vitro Companion Diagnostic Devices” published in August 2014.

If the CDx can meet the requirements set up in this guideline, in the “Intended Use” section, it can be declared that this CDx is applicable for the same group of oncology therapeutic drugs. In addition, all the applicable approved oncology therapeutic drugs need to be listed in the same section of IFU. Taking EGFR tests as an example. NMPA has approved several tyrosine kinase inhibitors, such as Afatinib, Erlotinib, Gefitinib, Osimertinib, Dacomitinib, and Icotinib, which are all indicated for the treatment of NSCLC patients with EGFR 19del or L858R mutations. They can be classified into the same group of therapeutic agents. In the IFU, the intended use of the test can be described as follows: “This kit is used for the qualitative detection of EGFR gene variants in neutral formalin-fixed paraffin-embedded (FFPE) tissue samples from NSCLC patients. Among them, 19del and L858R mutations can be used for tyrosine kinase inhibitor treatment with corresponding indications approved by the NMPA”. It is recommended to list the specific drug names in the form of a table.

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