China’s Food and Drug Administration (CFDA) announced on August 23 that all applicants for GMP certification for pharmaceutical products must now submit their materials electronically. According to the Chinese language notification, materials must be submitted to the website of the Center for Certification of Drugs in order to schedule a facilities inspection.
Previous applicants — including those companies that have been notified of passing certification inspection — should also submit their application materials to the website. These materials must be uploaded by September 30, 2013.
The new electronic applications do not take the place of paper dossiers, which are still required. In its notice, the CFDA says the new process will improve the implementation of GMP standards and facilitate the faster scheduling of inspections.