XN000022-1996-03-13 — Page 40

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(b)

(c)

whether the Government adopts different approaches in the registration and regulation of Chinese and Western medicines; and

whether the Government has conducted any tests or imposed any regulation on proprietary Chinese medicines available in the market; if so, what criteria the Government has adopted in determining which medicines should be selected for tests and regulation?

Reply:

(a)

(b)

(c)

The Pharmacy and Poisons Ordinance provides for the registration and control of pharmaceutical products and medicines that are to be sold in Hong Kong. Section 37 of the Ordinance provides for the exemption of this requirement for traditional Chinese medicines as listed in the Chinese Herbal Materia Medica or which are made from herbs customarily used by Chinese people. Hence Chinese proprietary medicines not containing western drug ingredients are not required to be registered.

The mode of control of western medicine stipulated under the Pharmacy and Poisons Ordinance follows international practice, which is not directly applicable to Chinese medicine. Regulation of Chinese medicine in the long term is a subject which will be considered by the Preparatory Committee on Chinese Medicine.

The Department of Health regularly takes random samples of proprietary Chinese medicines to analyse for the presence of western drug ingredients and the level of heavy metals. Medicines containing western drug ingredients are required to be registered as in the case of western medicines. The level of heavy metal is checked to ensure that it does not exceed the safety limit.

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