China Creates Administrative Service Center to Oversee Licensing for New Medical Devices and Drugs

In April 2006, the Chinese government opened a new Administrative Service Center to handle license applications for new medical devices and drugs in China more efficiently. This center, which is part of the State Food and Drug Administration (SFDA), will undertake administrative functions such as administrative acceptance, certificate making and delivery, and announcements. The center will also screen the registration applicants and their respective products to ensure that they are qualified to apply for product licenses.

Until now, the administrative acceptance, technical evaluation, and approval processes were “bundled.” The new Administrative Service Center separates the administrative process from the evaluation and approval processes, and will only perform “format” checks instead of substantial content checks. The new center will serve as a one-stop shop for these administrative services and will be held accountable for processing applications within certain time limits. The stated goal of the new center is to provide open, transparent, efficient, and convenient services to the applicants. It is also hoped that the increased transparency and accountability promoted by the new service center will help to minimize the opportunity for corruption in the SFDA.