2、Combined inspection procedure to conform to international standards
On October 29, 2013, CFDA published the CFDA Notice on Matters Related to Pharmaceutical GMP Certification Inspection (SYJYHJ [2013] No.224) as a major adjustment on the working procedures of GMP certification inspection and on-site inspection.
As mentioned in the notice, in drug registration process of new drugs and drugs applying for new drug registration, drug companies can apply for registering both on-site inspection for production and that for drug GMP certification simultaneously. For drug GMP certification implemented by CFDA, the two inspections will be combined and implemented by the drug certification management center of CFDA; for drug GMP certification implemented by a provincial administration, combined inspection will be implemented by both the said center and the provincial administration. Combined inspection shall meet all relevant requirements. Qualified companies will receive a Pharmaceutical GMP Certificate according to procedures after they obtain the approval file numbers for their drugs.
In addition, according to reliable sources, at least 7 Chinese companies have received the review and inspection by CFDA through combined inspection. Similar to its foreign counterparts, the new model no longer requires multiple inspections on a single company but provides one-time inspection during the stage of production registration. Upon combined inspection and obtaining the approval file number, companies need no further GMP certification inspection and receive the GMP certificate directly.
The adjusted regulatory model, similar to the current regulatory models in Europe and America, enables faster inspection and fewer burdens on companies. Nevertheless, the model also requires the company to have GMP management capacity for its product when it receives on-site inspection. Therefore, R&D companies need to put ahead their work required for GMP certification, which would increase phased cost.
