Press Release

Subsidiary Legislations for the Regulation of Chinese Medicines

November 1, 2002

The three subsidiary legislations for the regulation of Chinese medicines, namely the Chinese Medicines Regulation, the Chinese Medicines Traders (Regulatory) Regulation and the Chinese Medicine (Fees) Regulation, are gazetted today (November 1).

A spokesperson of the Department of Health (DH) said : "The Chinese Medicine Council of Hong Kong has formulated regulatory measures for the licensing of Chinese medicines traders and registration of proprietary Chinese medicines and incorporated them into the Chinese Medicines Regulation and the Chinese Medicines Traders (Regulatory) Regulation, whereas the Chinese Medicine (Fees) Regulation specifies the charges for the licensing of Chinese medicine traders and registration of proprietary Chinese medicines."

"The Council and DH have conducted extensive consultations including more than 20 seminars/ forums about the subsidiary legislations for the regulation of Chinese medicines. Apart from safeguarding public health, the operation of the trade and the development of Chinese medicine in Hong Kong have been taken into consideration. It is also hoped that the proposed control measures will increase the competitiveness of Chinese medicine products of Hong Kong in the global international markets."

"The three regulations will be submitted to the Legislative Council for scrutiny. Upon enactment of the regulations, their implementation will be by phases from next year. Following the completion of licensing procedures for Chinese medicine traders, the registration of proprietary Chinese medicines will commence," the spokesman said.

In July 1999, the Legislative Council enacted the Chinese Medicine Ordinance (Cap.549) (the Ordinance), which provides a regulatory framework for the practice of Chinese medicine in Hong Kong and for the use, sale and manufacture of Chinese medicines. Formed in accordance with the Ordinance in September 1999, the Council is responsible for formulation and implementation of the regulatory measures. The Ordinance stipulates that all traders engaging in the retail and wholesale of Chinese herbal medicines and in the manufacture and wholesale of proprietary Chinese medicines shall apply for appropriate licences, while all proprietary Chinese medicines manufactured or sold in Hong Kong shall be registered with the Council.

The three regulations are summarised as below:

• Chinese Medicines Regulation

The Chinese Medicines Regulation sets out the licensing requirements for Chinese medicines traders, including the provision of sufficient space at their practising premises, keeping the environment in hygienic conditions, maintaining appropriate facilities to carry on operation and ensuring that the supervisors responsible for dispensation of Chinese herbal medicines and manufacture of proprietary Chinese medicines possess the required knowledge and experience. The traders shall also maintain appropriate records so as to facilitate tracing of the origin of medicines.

As for proprietary Chinese medicines, the traders must submit objective evidence to demonstrate that their products comply with the safety, quality and efficacy requirements, before the proprietary Chinese medicines are registered. Particulars of registration will include active ingredients, indication, administration, label and package insert, etc. of the products.

• Chinese Medicines (Regulatory) Regulation

The Chinese Medicines (Regulatory) Regulation sets out the procedures to be taken in handling complaints against or misconduct of licensed Chinese medicines traders, which includes case investigation, giving representation and explanation by the traders concerned and holding of meetings, etc.

• Chinese Medicine (Fees) Regulation

The Chinese Medicine (Fees) Regulation sets out the charges for licensing of Chinese medicines traders and registration of proprietary Chinese medicines. It is the Government's general policy to fix all fees on a full cost-recovery basis. After consultations with the trades, the Government suggests that to alleviate their financial burden, the fees for the licensing of Chinese medicine traders were fixed initially at about 70% of the cost, while that for registration of proprietary Chinese medicines were lower than 30% of the cost (for example, the registration and verification fee for proprietary Chinese medicines containing multiple active ingredients is $2,000, which accounts for a cost-recovery rate of 25.2%). However it is planned that the fees shall be adjusted to the full cost-recovery level in five years.