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New drug system unveiled



The State Drug Administration (SDA) is expected to implement a prescription and non-prescription drug classification system beginning January 1.

Under the new management system, all medicines will be categorized as prescription or non-prescription drugs.

The latter may be referred to and will be made available as over-the-counter (OTC) drugs or remedies.

Prescribed medicines must be sold and used under the guidance of medical professionals; OTC medicines will be available without prescriptions, but will have instructions for users listed on containers or packages.

"The dual system will enable consumers to buy safe and effective medicines from pharmacies,'' said Zheng Xiaoyu, director of the SDA.

'' They will not have to worry about accidents stemming from a lack of professional guidance," Zheng said.

Chinese medical doctors and pharmaceutical specialists have selected 165 varieties of western medicine and 160 varieties of Chinese medicines for OTC sales at pharmacies.

By the end of September next year, drug administration departments at various governmental levels are expected to complete examinations and registrations of drugs or remedies based on the OTC medicine list.

Labels and instructions on OTC medicines must comply with State standards that require science-based labelling that is easy to understand and convenient for consumers to choose and use.

OTC medicines will be subdivided into a Group A or Group B classification based on their perceived safety level. They must be specially labelled.

The Chinese Government has been working on this issue since 1996.

The SDA has produced a series of documents and regulations related to medicine management.

The governmental body has been conducting experiments in three areas and with seven medicine manufacturers chosen to help implement the medicine management plan.

"Setting up the new management system will be a long and complicated process as a result of great differences between local and regional areas," said Zheng.

The work should be accomplished within two or three years, and it is expected to provide a higher level of safety for Chinese people who need sound medical advice.

(From China Daily)

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