China FDA Issues Guidance on Accepting Foreign Clinical Data for Medical Devices

China FDA will soon begin accepting foreign clinical data for medical devices as part of a national effort to promote industry innovation and to remove barriers to expediting reviews.

It recently released technical guidance that outlines requirements for those planning to submit foreign clinical data, and said the efforts will also help to avoid duplication for companies conducting global clinical trials.

The new guidance provides details on the clinical trial data needed to assess the safety and efficacy of medical devices and in vitro diagnostics intended for registration in China.

The guidance notes that clinical trials conducted abroad should conform to CFDA good clinical practices (GCP). If a trial is conducted in a country that does not have GCP requirements, the differences should be described in detail to demonstrate that they will not have an effect on the authenticity, scientific rigor, and reproducibility of research results, and that human research subjects will be protected.

Applicants should include a clinical trial plan and ethics committee opinion. They should confirm that the population data studied can be extrapolated to the Chinese population, and they should contact China’s Center of Medical Device Review before submitting the data from clinical trials conducted in foreign countries.

These moves are expected to create a level playing field for R&D-focused device companies at home and abroad, according to the law firm Ropes & Gray in Shanghai.

Launches of imported devices have historically lagged behind first device launches in their country of origin because the CFDA required advance approval on a phase-by-phase basis before clinical trials could begin.

Further, the “shortage of CFDA-qualified clinical study sites limits the infrastructure for clinical development, and increases study costs,” the attorneys said.

CFDA also intends to enhance the clinical trial approval process. It will allow devicemakers to begin clinical trial studies following a 60-day waiting period if the CMDE does not object to their application filing or issue a deficiency notice.

Devices that offer new solutions for treating life-threatening diseases or address critical unmet medical needs could be eligible for conditional approvals, as long as early and mid-stage study data indicate efficacy and clinical value. Those approved outside of China that offer new solutions for treating rare diseases will also be eligible for conditional approvals.

China recently tightened up on its policing of clinical trials, with the Supreme People’s Court requiring stricter punishments for companies falsifying clinical trial reports (IDDM, Oct. 16).