China Regulatory Updates (March 2026)

On January 7, 2026, China’s National Medical Products Administration (NMPA) announced measures to expedite the approval of drugs already approved outside of China that are urgently needed in clinical practice. The Centre for Drug Evaluation (CDE) will assess the clinical demand of drugs on a case-by-case basis, instead of a predetermined list. In addition to a priority review to shorten technical review timelines, applicants may attend an early consultation with the CDE on clinical trials to determine if a Chinese clinical trial may be exempted. Requirements for registration testing for orphan drugs are also relaxed, as now only one batch of samples will be required. Pre-registration quality inspections may be remote or combined with post-marketing checks to further speed approvals.

Also, China’s Center for Medical Device Evaluation has issued a new draft guidance on the 2026 catalogue of Class III medical devices that will need regulatory clearance prior to conducting clinical trials. The proposal, which updates the 2020 version, outlines nine high-risk device areas that would require prior approval if certain novelty criteria are met. Under China’s regulatory framework, advanced authorization for clinical trials is not required for all devices. This rule mainly applies to higher-risk Class III products that introduce new materials, mechanisms, designs, or clinical uses. If a device’s name and description match an entry in the catalogue and it demonstrates the abovementioned novelty, sponsors would need approval before commencing trials. The draft focuses on complex or implantable technologies where design and performance are closely linked to safety such as implantable cardiac rhythm devices, ventricular assist systems, drug infusion pumps, heart valves and stents, etc. Public comments are being accepted through March 5, 2026.