China’s $22.5 billion pharmaceutical market is the second largest in Asia, after Japan, and foreign drug imports and pharmaceutical investment in China will likely increase as China enters the WTO. Anticipating an influx of foreign pharmaceuticals, the Chinese government established the State Drug Administration (SDA) in March 1998, an organization created to oversee drug importation through law and inspection.
The SDA consolidates the former State Pharmaceutical Administration of China (SPAC), the Bureau of Drug Policy Administration (BDPA) and the State Administration of Traditional Chinese Medicine (SATCM). The new organization’s goals are to streamline the enforcement and inspection processes, as well as to “clean up” China’s domestic medicine market to increase its competitiveness for China’s WTO accession. The SDA has authored several revised regulations since its conception, including the “Provisions for Import Drug Approval.”
DRUG IMPORTATION PROCESS
The Chinese government defines an import drug as one that is approved, manufactured, and marketed in a foreign country, for which an application is filed for its registration and sale in China. The “Provisions for Import Drug Approval” outline three initial requirements for import drug registration before a foreign pharmaceutical manufacturer should consider the more extensive technical requirements:
1. The drug must meet a clinical need, comply with safety and efficiency standards, and be quality controllable.
2. The country in which the drug is manufactured must approve it for domestic sale.
3. The foreign pharmaceutical manufacturer must comply with Good Manufacturing Practices.
Once the foreign pharmaceutical manufacturer has met these general standards, it must then fulfill the dossier requirements, which include:
• Free Sale certificate and GMP certificate (Chinese translation required);
• Document of applicant’s qualifications;
• Patent certificate;
• Package circular (Chinese translation required);
• Specification and analytical methods (Chinese translation required);
• Summary of product development, manufacturing, sale, and use of the drug in other countries (Chinese translation required); and
In addition, the manufacturer must include the following technical data:
• Chemical data: structure/formulation (Chinese translation required), manufacturing process (Chinese translation required), and stability
• Non-clinical data: general pharmacology, acute and long-term toxicity, mutagenicity, teratogenicity, carcinogenicity, dependence, and animal pharmacokinetics
• Clinical data: clinical traits including protocol, statistical analysis, and bioavailability/bioequivalence.
APPLYING FOR AN IMPORT DRUG LICENSE
To begin the application process, the pharmaceutical manufacturer’s representative, or its authorized agent in China, must open a file with the SDA. The SDA must then verify the quality specification and perform a sample test upon three batches of the drug, though the SDA has the option of granting an exemption to clinical study. “Fast track” distribution of life-saving or emergency drugs is also available through an accelerated review option.
The State Drug Administration awards a successful application with an “Import Drug License,” a legal document that grants the manufacturer the right to register, import, sell, and use the import drug in China. The license remains active for a three-year, renewable period. The Import Drug License identifies the following:
• Generic name
• Trade name
• Active ingredient(s)
• Dosage form
• Strength (package size)
• Package size
• Shelf life
• Product specification (manufacturing process)
• Name and address of the company and manufacturer
• Duration of license
• License number
• Date of issuance
Foreign pharmaceutical manufacturers should apply to renew the Import Drug License with the SDA six months prior to the expiration date. If a product fails import drug quality inspections twice, the SDA must deny license renewal.
REQUEST FOR LICENSE CHANGES
If any changes are made to the specifications and provisions listed on the Import Drug License, a Supplemental Application must be filed with and approved by the SDA. A Supplemental Application is also required for a foreign pharmaceutical manufacturer to claim additional indications (additional clinical studies are generally also necessary). Changes in a drug’s specifications also require a Supplemental Application, to be accompanied by a verification and review period.
Finally, the foreign pharmaceutical manufacturer should also file a Supplemental Application to change the contents of the package circular (package label format or content).
The Supplemental Application must be filed twelve months prior to the expiration date of the Import Drug License. If the license expires in less than 12 months, the drug manufacturer may file the Supplemental Application along with the Renewal Application.