White paper: China tightens supervision of prescription drugs

2008-07-18 02:41:56 GMT       2008-07-18 10:41:56 (Beijing Time)       Xinhua English

BEIJING, July 18 (Xinhua) -- In recent years, China has increasingly tightened its supervision of prescription drugs, says a white paper published by the Information Office of the Sate Council on Friday.

Since 1995 China has been working on a drug classification system. The country promulgated the Measures for the Administration of Classification of Prescription and Over the Counter (OTC) Drugs (trial) in 1999 and gradually implemented the classification management between prescription and OTC drugs, it says.

In order to select, examine and approve OTC drug types as well as make necessary distinctions between some prescription and OTC drugs, China has publicized 4,610 types of OTC drugs, including Chinese patent medicines, the paper says.

China regulated the administration of OTC drugs, formulated a prototype manual for OTC drugs with detailed contents, and publicized a specific logo for OTC drugs, it says.

The drug regulatory departments have integrated the drug classification management with Good Supply Practice (GSP) certification for drug retailing enterprises, and promulgated regulations that prescription and OTC drugs must be displayed in separate shelves, no open-shelf self-service for prescription drugs, and classification management for pharmacies, according to the paper.

The supervision of the administration of advertisements for prescription drugs has been tightened, and the mass media carrying advertisements for prescription drugs has been stopped, says the paper.

China has steadily promoted a management mode of selling prescription drugs only to people with doctor's prescriptions, and promulgated compulsory measures for the sale of 11 categories of prescription drugs, including injections, and antibacterial and hormone drugs that can be bought only with prescriptions, says th epaper.

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