Abstracts of China's Laws and Regulations Related to Pharmaceutical Sector   

The Drug Administration Law of China, effective July 1st, 1985, ruled that any drug-making company must be approved by authorities at provincial, autonomous regional or municipal levels, and must obtain a production license from local health regulators.
   Pharmaceutical companies must work out their own production regulations, in accordance with requirements by the Ministry of Health under the State Council, and implement them to ensure drug quality and sanitation levels.
   In developing new drugs, companies must submit the information and samples regarding their research methods, quality indicators and test results for toxicology and pharmacology to the state-level health authorities for approval before conducting clinical tests and authentication.
   The authorities will approve new drugs if clinical appraisals prove successful upon completion, and then grant certificates to them.
   When producing new drugs, companies must obtain the approval reference numbers from the drug regulators under the State Council.
   When they import a certain medicine for the first time, importers must also provide the medicine's instruction sheets and other related information and samples representing quality standards and test methods as well as files which could document its production license from its country of origin. Imports must be approved by health authorities before signing import contracts.
   All imported medicines must undergo inspections by agencies authorized by the health regulators before they can be imported.

The Regulations for the Implementation of the Drug Administration Law of China, effective on September 15th, 2002, ruled that a pharmaceutical production license has validity of five years since issuance.
   The pharmaceutical raw materials used by drug makers must be with a reference number issued by the health regulators or a registration certificate for imported medicines.
   Any medicine to be imported must have gained approval for sale in markets of their origins. Otherwise they must be confirmed to be effective in clinical tests by China's pharmaceutical regulators in accordance with the Drug Administration Law before they are sold to China.
   Imported drugs should be registered based on medicine regulation's rule. Drugs made by foreign companies need registration certificates for imported drugs and those made by companies in Hong Kong, Macau and Taiwan need registration certificates for pharmaceutical products .
   The approval reference number, the registration certificate for imported drugs and the registration certificate for pharmaceutical products issued by the drug regulators each have a validity of five years since issuance.

At present China also enforces the Regulations on the Control of Anesthetic and Psychoactive Drugs (effective August 3rd, 2005) and the Anti-doping Regulations (effective March 1st, 2004).
   The State Food and Drug Administration, directly under the State Council, is the regulating agency for foods, health care products, cosmetics and drugs.