The China Food and Drug Administration (CFDA) is responsible for the supervision and inspection of drugs.
(a) Supervision and Inspection of Import drugs
China Registration of import drugs
China implements a registration and approval system for import drugs. Under the Measures for Administration of Drug Registration which came into force on 1 October 2007, all import drugs must obtain an Import Drug Registration Certificate from CFDA. Manufacturers of Hong Kong, Macau and Taiwan must obtain a Pharmaceutical Product Registration Certificate for their drugs applying for registration. The import drug production plants must meet the drug production and quality control standards of the producing country as well as the requirements of China¨s Good Manufacturing Practice (GMP). Drugs applying for import into China must be granted approval for public sale by the local authorities of the producing country or region, unless the drug is confirmed by CFDA to be safe and effective, and meet clinical needs. Drugs applying for import into China must comply with the GMP drug production requirements of both the producing country or region and China.
The China office or registered agent of the foreign drug manufacturer is responsible for applying for import drug registration. They have to submit the Import Drug Registration Certificate Application Form together with other required documents to CFDA for examination and approval. These offices or agents must be legitimate establishments registered with China¨s industry and commerce administration authorities.
After reviewing the quality of the drug and organising the necessary clinical studies, CFDA will grant an Import Drug Registration Certificate to the import drugs in question. This certificate is the official approval document for the registration, import, sale and use of foreign drugs in China.
Filing of imports
Drugs must be imported through designated ports of entry and the importer must register and file the import with the drug administration at the port of entry. Any change in the packaging as well as the form and content of labelling must be reported to CFDA.
Application for inspection
Inspection organs: The port-of-entry drug laboratories set up by CFDA are the inspection authorities for registered import drugs. Drugs must be imported through port cities where port-of-entry drug laboratories are located. These laboratories would not inspect drugs imported via other ports of entry.
Application procedures: After the import drugs have arrived at the port of entry, the importing enterprise has to complete the Import Drug Inspection Form and submit it to the local port-of-entry drug administration together with the Import Drug Registration Certificate or Pharmaceutical Product Registration Certificate (original or copy), (and an additional Import Permit for the import of narcotics and psychotropic drug) as well as other related documents. After verifying all the documents, the port-of-entry drug administration will issue a Port-of-entry Inspection Notice for Import Drug to the local port-of-entry drug laboratory. After inspection, the laboratory will submit a report to the local port-of-entry drug administration. Drugs meeting the requirements will be issued an Import Drug Clearance Slip by the port-of-entry drug administration while those not meeting the requirements will be issued a Filing Notice of Drug Import Rejection.
Re-inspection and arbitration: The importing enterprise may apply to the original port-of-entry drug laboratory or the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP) for re-inspection within 7 days upon receipt of the inspection report if it objects to the results of inspection. Application for re-inspection of biological products should be made directly with NICPBP.
(b) China Supervision and Inspection of Export Drugs
Supervision of drug production
Production licence: Drug manufacturers in China must be approved and issued a Drug Production Licence by the local provincial-level drug administration, and must register with the industry and commerce administration department by presenting the Drug Production Licence.
Quality certification: Drug manufacturers must undertake production in accordance with the Quality Control Standards for Drug Production formulated by the drug administration authority under the State Council. The competent drug administration authority is responsible for certifying whether or not an enterprise complies with these standards and will issue a certificate to those qualified.
Enterprises may request a drug laboratory established by the health department to prepare a report on the inspection of drugs for export. The criteria of inspection are generally in accordance with the export contract.