China NMPA/CMDE Releases Draft Guidance for Mycobacterium tuberculosis Complex Drug-Resistance Mutation Detection Kits (2026 Revision)

On September 16, 2026, the CMDE of China’s NMPA published a notice soliciting public comments on the Draft Guidance for the Registration Review of Mycobacterium tuberculosis Complex Drug-Resistance Gene Mutation Detection Reagents (2026 Revision). The public comment period closes on October 15, 2026.

The draft guidance aims to standardize technical review requirements and further guide applicants in preparing and drafting registration submission materials. It applies to reagents that use molecular biology techniques for in vitro qualitative detection of drug-resistance gene mutations in M. tuberculosis complex from clinical samples or cultured isolates of tuberculosis patients.

The scope defines two product forms. Single-function reagents detect only drug-resistance gene mutations. Dual-function reagents detect both M. tuberculosis complex nucleic acid and drug-resistance mutations. For dual-function reagents, the nucleic acid detection part follows the 2025 guidance for M. tuberculosis complex nucleic acid detection reagents, while the drug-resistance mutation part follows this draft guidance.

The draft establishes three intended-use categories based on result reporting. Type A reagents can distinguish and report specific mutation types. Type B reagents can detect known mutation sites but do not distinguish among them, reporting only resistant or susceptible status. Type C reagents cover situations where any mutation within a nucleic acid region may cause resistance, and specific mutation sites are not distinguished.

For non-clinical studies, the draft details analytical performance requirements, including sample stability, accuracy, precision, limit of detection, analytical specificity, cross-reactivity, interference studies, and reaction system optimization. For limit of detection, it considers both a 100% resistant proportion and mixed resistant/wild-type populations at different ratios. National reference materials for rifampicin and isoniazid resistance detection are already available and should be used where applicable.

For clinical trials, at least three registered medical device clinical trial institutions are required. For single-function reagents, the target population is tuberculosis patients with M. tuberculosis complex-positive samples. For dual-function reagents, the target population is suspected tuberculosis patients. Comparative study designs and sample size estimation formulas are provided for products with and without listed predicate devices on the market.

The draft also covers product technical requirements, stability studies, positive cutoff value determination, main raw material research, and instructions for use. Main raw materials include primers, probes, enzymes, dNTPs, controls, and enterprise reference materials.