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Following is a question by the Hon Fred Li and a reply by the Acting Secretary for Food and Health, Professor Gabriel Leung, in the Legislative Council today (May 19):
Question:
On March 24 this year, after learning that the Health Sciences Authority in Singapore had found two western drugs namely, "phenolphthalein" and "sibutramine", in samples of "Po Chai Pills Capsule Form", the Department of Health (DH) directed the manufacturer concerned to recall from local retail outlets and consumers this proprietary Chinese medicine (PCM), in respect of which an application for registration is being processed. DH announced the results of the tests on that PCM on March 29 that six capsule form samples and five samples from powder for making capsules were found to contain the aforesaid western drugs. The powder was traced to a company called "廣東施健生物科技有限公司" (Guangdong Shi Jian Biotechnology Company Limited), but the company is not on the list of Guangdong's drug manufacturers. In this connection, will the Government inform this Council:
(a) whether at present it is an offence to sell in Hong Kong PCMs which have not been registered or transitionally registered; if so, why the aforesaid unregistered PCM can be sold in Hong Kong; whether the authorities have formulated guidelines on the recall of PCMs and the refund mechanism;
(b) of the respective numbers of PCM manufacturers holding a PCM manufacturer licence and a transitional certificate at present; whether the authorities have set a timetable for full compliance with the licensing requirements by PCM manufacturers and of the support measures in place to facilitate PCM manufacturers in meeting the licensing requirements; whether the terms of the PCM manufacturer licence provide for the regulation of the procurement of PCM raw materials; and
(c) of the current manpower responsible for the registration of PCMs, licensing of PCM manufacturers, inspection of PCM manufacturing plants, testing of PCMs and provision of support for the recall of PCMs respectively?
Reply:
President,
The Chinese Medicine Ordinance (the Ordinance) was enacted in July 1999. The two major sets of regulatory measures, namely licensing of Chinese medicines traders and registration of proprietary Chinese medicines (pCm) were implemented in April and December 2003 respectively under the Ordinance.
The regulation of Chinese medicines is undertaken by the Chinese Medicines Board (CMB) under the Chinese Medicine Council, with professional and administrative support provided by the Department of Health (DH). Details of these two sets of regulatory measures are as follows:
Chinese medicines traders licensing system:
Any persons engaged in retail and wholesale of Chinese herbal medicines, and manufacture and wholesale of pCm are required to apply for a licence with CMB.
To enable Chinese medicines traders to continue operating their existing business in Chinese medicines, the Ordinance provides for a transitional licensing arrangement, allowing Chinese medicines traders who were already in business on January 3, 2000 to apply for a licence through such transitional arrangement.
Registration of pCm:
For products that fall within the definition of pCm, application for registration of pCm must be made to CMB. These products must meet the requirements prescribed by CMB as regards their safety, quality and efficacy in order to get registration.
Our replies to various parts of the question are as follows:
(a) Chinese medicine has a long history. In the transition from no formal regulation in the past to implementation of comprehensive legislative regulation, we need time to establish and consolidate our regulatory system, and the trade also needs time for adaptation and preparation in order to comply with the legislative requirements. In view of this, we have adopted a phased approach in implementing the regulatory system. Regulation was imposed on Chinese medicine practitioners first and then on Chinese medicines traders and pCm.
By virtue of the Ordinance, any pCm which is, on March 1, 1999, manufactured, sold or supplied for sale in Hong Kong is eligible for transitional registration. This is due to the considerations that no regulatory mechanism for pCm was ever put in place before the enactment of the Ordinance, and quite a lot of pCm were already in frequent use and on sale for quite a long period of time. Manufacturers or agents of these pCm may apply to CMB for transitional registration of their pCm. A "Notice of confirmation of transitional registration of pCm" will be issued for applications which meet the eligibility criteria for transitional registration.
As at the end of April 2010, CMB received a total of 16,540 applications for pCm registration, of which 14,100 also made concurrent application for transitional registration. CMB has assessed all these applications for transitional registration and issued a "Notice of confirmation of transitional registration of pCm" for 9,120 applications and a "Notice of confirmation of (non-transitional) registration of pCm" for 2,100 applications for non-transitional registration in respect of which acceptable basic test reports had been submitted. In addition, 4,610 applications for registration of pCm were rejected for failing to furnish sufficient information.
In view of the fact that CMB has completed the assessment of all the applications for non-transitional registration of pCm, the Government has planned to put into full implementation the remaining provisions under the Ordinance related to mandatory registration of pCm by the end of this year. Sale, importation or possession of unregistered pCm in Hong Kong will be an offence by then.
Although the legislative provisions governing the registration of pCm are not yet in operation, licensed pCm manufacturers have to observe the law and the requirements of practising guidelines, which include ensuring that the pCm manufactured and distributed meet the quality requirements. Besides, a proper recall system should also be put in place in accordance with the "Practising Guidelines for Manufacturers of Proprietary Chinese Medicines". We will also make a recommendation to CMB for a review to be conducted as appropriate on whether a refund mechanism should be established.
Besides, DH will also conduct market surveillance by collection of Chinese medicine products available on the market and from premises of the Chinese medicine traders for testing on a regular basis. If any quality or safety problem is detected, DH will conduct investigation and take follow-up actions in accordance with the relevant requirements.
(b) As at the end of April this year, there are around 450 pCm manufacturers in Hong Kong and about 160 of them have been granted a formal licence. The remaining manufactures in the number of some 290 are holding a transitional certificate. CMB is now working in full swing to process the vetting of the applications from pCm manufacturers for conversion of their transitional certificates into formal licences and has set out the approval criteria and handling methods. CMB will give holders of transitional certificates a period of time of different length as appropriate to make improvements to their factory environment, relocation arrangements, as well as fittings and equipment. DH will actively work with CMB on vetting and expediting processing of such applications, with a view to completing the processing of applications from pCm manufacturers for conversion of their transitional certificate into a formal licence in less than two years.
While there is no regulation on the purchase of Chinese medicine raw materials by manufacturers under the current licensing system, manufacturers are required to conduct testing on their pCm as to whether they meet the safety and quality standards in the process of manufacturing their pCm. Manufactures without the relevant testing capability may commission a testing body to conduct the work on quality control. Manufacturers should also purchase their ingredients from reputable suppliers and follow the steps on inspection and acceptance of the ingredients to ensure the safety and quality of their products.
(c) There are about 90 officers deployed in DH to undertake the licensing, inspection and enforcement work relating to Chinese medicine traders and registration of pCm. They comprise 25 pharmacists, one Scientific Officer, four Assistant Chinese Medicine Officers, 20 Chinese Medicine Assistants, and some 40 general clerical and administrative support staff. Eleven additional posts will be created in 2010-11 to strengthen the manpower support for the relevant work.
President, I would like to stress that there are substantial differences between Chinese medicines and Western medicines in terms of their principles and applications. We have encountered immense challenges in the process of devising a regulatory system for Chinese medicine. The World Health Organisation also recognises that regulation of Chinese medicines is extremely difficult, as the quality and efficacy of Chinese herbs may be affected by various factors, and researches on Chinese medicines are also inadequate worldwide. The regulatory system for Chinese medicine is at its early stage of development whether it is in Hong Kong or in other places of the world. In the process of developing a regulatory system, there is not much we can draw reference from. Hong Kong is considered one of the forerunners in the development of a comprehensive regulatory system. We will actively conduct researches in Chinese medicines including the setting of standards for 200 commonly used Chinese herbal medicines. We will also continue to work closely with the trade and tackle any challenges in joint efforts with them to ensure the safety, efficacy and quality of Chinese medicines.
Ends/Wednesday, May 19, 2010
Issued at HKT 14:48
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