Pharmaceutical Industry Reform in China: New Drug Administrative Law

In line with its accession to the World Trade Organization (WTO), the Chinese government promulgated a new Drug Administrative Law effective December 2001. New clauses address drug quality control, labeling and advertising restrictions, and other issues related to safety and improving standards for China’s pharmaceutical industry.

Under the new law, stricter labeling requirements are indicated. Usage instructions and accurate specifications must be printed on the drug packaging and labels. Packaging and labels must also be written predominantly in Chinese and follow the specific text format established by the government (foreign translations may also be included). Companies will not be allowed to use inconsistent packaging for identical drugs — in other words, the same drug may not be packaged in a number of different ways to mislead or confuse the customer. However, similar products with different specifications must be labeled clearly so that consumers may easily compare the products. Any variations of a drug must be noted on the package. Expiration dates must be accurate and clearly marked as well. While these requirements are generally in line with standard international practices, historically China has not monitored pharmaceutical labeling very carefully.

The new Drug Administrative Law also includes rules to prevent negligent ads and will eventually ban any form of prescription drug advertising. Beginning in February 2001, ads for drugs that treat angina, high blood pressure, hepatitis, and diabetes have been banned. By the end of 2002, prescription drug advertisements will be completely abolished. For non-prescription drugs, the SDA must approve the drugs’ recommended usage and instructions in order to be advertised. Drugs advertisements that meet local standards, but not national government standards, will be prohibited starting July 1, 2002.

The new law impacts imported drugs as well. Imported drugs must meet quality and safety standards in order to receive an import drug registration certificate. Foreign firms must submit an application, citing scientific evidence of the drugs’ qualifications, and undergo quality examinations. Foreign drugs without a certificate of registration will be considered as counterfeit drugs. In addition, import drugs must adhere to the same packaging and labeling rules as domestic drugs and must also include an “imported drug registration number” and manufacturer’s name on their packaging.

It is too early to know whether or not these new rules will be adequately enforced. Historically, China has a reputation for lax and uneven enforcement of its pharmaceutical laws. However, the SDA has made marked progress in the past several years. Now that China is a WTO member, enforcement is likely to strengthen further.