Expanding on recent reforms allowing innovative pharmaceutical drugs to be approved on the basis of overseas clinical trial data, China’s National Medical Products Administration (NMPA) has created special channels for the approval of new pharmaceuticals subject to “urgent” clinical needs.
On the heels of its July 10 Technical Guidelines for the Acceptance of Overseas Clinical Trial Data for Drugs, the NMPA (formerly known as the China Food and Drug Administration, or CFDA) has created a “special channel” for the fast-track approval of urgently needed pharmaceutical drugs developed overseas through its Review and Approval Procedures for Urgently-Needed Pharmaceutical Drugs Developed Overseas, published on October 30, 2018 (the Procedures).
This reform is the latest step in the regulator’s push to remove obstacles to bringing pharmaceuticals developed overseas to the Chinese market. The July 10 guidelines described rules by which pharmaceuticals may gain approval for sale in the China market on the basis of overseas clinical trial data, reducing the delays and costs for Chinese consumers. The special channel will further accelerate the process for select drugs.
The special channel will be available for pharmaceuticals that have been approved and marketed in either the United States, the European Union, or Japan in the past 10 years but have not yet been approved in China, and that meet any one of the following criteria:
Pharmaceuticals meeting these criteria will be selected by the NMPA and National Health Commission (NHC) for inclusion within the Catalogue of Urgently-Needed Overseas Pharmaceuticals (the Catalogue). The NMPA’s Center for Drug Evaluation (CDE) will conduct preliminary screenings for candidates, which will then be submitted to the NMPA and the NHC for further review and verification by a designated panel of experts. Upon the experts’ review and verification, the CDE will publish a draft of the catalogue on its website for five days of public comment, after which, if approved, the final catalogue will be released by the CDE, subject to any modifications on the basis of public commentary.
On November 1, 2018, the CDE released the first catalogue, containing 40 separate pharmaceuticals, while an additional eight drugs have already received fast-track approval for sale on the Chinese market.
Once a specific drug is listed in the catalogue, market authorization holders may apply directly to the NMPA for approval without the need to conduct clinical trials in China, provided the application includes acceptable overseas clinical trial data along with an “ethnic sensitivity analysis” demonstrating that the drug is safe and effective for use in the Chinese population. Drugs that have been approved and marketed in Japan, Hong Kong, Macau, and/or Taiwan may be exempted from the ethnic sensitivity analysis requirement, provided that such drugs are supported by sufficient clinical data.
Once accepted for fast-track review through the special channel, applications for treatments of rare diseases or conditions will be reviewed within three months, while other drugs used to treat or prevent serious or life-threatening illnesses will be reviewed within six months. However, actual approval times may be longer if additional documentation is required.
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact the author, Todd Liao (Shanghai).