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Following is a question by the Dr Hon Lam Tai-fai and a written reply by the Acting Secretary for Food and Health, Professor Gabriel Leung, in the Legislative Council today (April 28):
Question:
Since the Government implemented the registration system for proprietary Chinese medicines (PCM) (the registration system) in 2003, manufacturers and importers of PCM are required to submit applications to the Chinese Medicines Board of the Chinese Medicine Council (the Medicines Board) for PCM registration. Moreover, under section 119 of the Chinese Medicine Ordinance (the Ordinance) (Cap. 549), except under exemptions given in the Ordinance, no person shall sell, import or possess any unregistered PCM. The provision has yet to come into operation at present. In this connection, will the Government inform this Council:
(a) of the total number of Hong Kong-invested licensed PCM manufacturers and the number of registered PCM in Hong Kong at present, and whether it knows their respective market share;
(b) of the annual number of licensed PCM manufacturers that have voluntarily reported on the problems of their registered PCM since the implementation of the registration system, together with the date and content of the reports submitted, as well as the authorities' follow-up actions, set out in table form;
(c) given that at present, licensed PCM manufacturers are required to submit to the Medicines Board reports on the tests on safety, efficacy and quality, etc. of the medicine when making applications for PCM registration, whether the authorities know the average cost of each report on such tests and the time needed to complete each report;
(d) whether there is any measure in place to assist Hong Kong-invested licensed PCM manufacturers in conducting safety tests on medicines and researches; if so, of the details; if not, the reasons for that;
(e) given that western medicines are required to comply with the standards of the "Good Manufacturing Practices" at present, whether the authorities have planned to require PCM to comply with such standards as well; if they have, of the details; if not, the reasons for that;
(f) whether the Department of Health has taken the initiative to conduct tests on the raw materials of PCM in the market, and inspect PCM manufacturing plants regularly; if it has, of the details; if not, the reasons for that; and
(g) when section 119 of the Ordinance will come into operation; before the provision comes into operation, what actions the authorities will take to ensure the safety of the PCM taken by members of the public?
Reply:
President,
We implemented the regulatory measures for licensing of Chinese medicines traders and registration of proprietary Chinese medicines (pCm) in April and December 2003 respectively under the Chinese Medicine Ordinance (CMO), aiming at better safeguarding public health and enhancing public confidence in using Chinese medicines. Details of these two sets of regulatory measures are as follows:
Chinese medicines traders licensing system
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Any persons engaged in any of the four types of Chinese medicines trade, i.e. retail and wholesale of Chinese herbal medicines, and manufacture and wholesale of pCm are required to apply for a licence with the Chinese Medicines Board (CMB) under the Chinese Medicine Council of Hong Kong (CMCHK). Applicants for Chinese medicines traders licences must meet the relevant licensing requirements before the relevant licence is issued. The licensing requirements for pCm manufacturers include sanitary premises, adequate space, adequate and suitable facilities for storing the ingredients used for manufacturing pCm, packing materials, intermediate products and pCm, suitable fittings and equipment for manufacturing pCm, as well as business premises being suitable in all other respects for carrying on a business in the manufacture of pCm. Besides, persons responsible for supervision of the manufacture of pCm should possess the appropriate level of knowledge and experience as prescribed in the Chinese Medicines Regulation.
To enable Chinese medicines traders to continue operating their existing business in Chinese medicines, the CMO 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 within the period from May 5, 2003 to July 15, 2003. The transitional licences will remain valid until the traders concerned are granted a formal licence or when their applications for a formal licence are rejected or until such date to be promulgated by the Secretary for Food and Health in the Gazette, whichever date is the earliest.
Under the licensing system, traders engaged in the retail or wholesale of Chinese herbal medicines, and manufacturers or wholesalers in pCm must obtain a licence from CMB. The maximum penalty for non-compliance is a $100,000 fine and imprisonment for two years.
Registration of pCm
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For products that fall within the definition of pCm (Note 1), application for registration of pCm must be made to CMB in accordance with section 121 of the CMO. All pCm must meet the registration requirements prescribed by CMB as regards their safety, quality and efficacy in order to get registration. For those pCm manufactured in Hong Kong, application for the registration must be made by the relevant local manufacturer. As for those manufactured overseas, application must be made by the local representative/agent of the overseas manufacturer or the importer concerned.
By virtue of Section 128 of the CMO, 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 CMO, and that prior to 1999, 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 within the application period specified by CMB (i.e. from December 19, 2003 to June 30, 2004). Subject to CMB's vetting and approval, a "Notice of confirmation of transitional registration of pCm" will be issued for applications which meet the eligibility criteria for transitional registration. Such a Notice will remain valid until the pCm is formally registered, or until the application for its registration is refused, or until such date to be promulgated by the Secretary for Food and Health in the Gazette, whichever date is the earliest.
Our replies to various parts of the question are as follows:
(a) Application for registration of pCm manufactured in Hong Kong should be submitted by the relevant local manufacturers. At present, there are about 500 local manufacturers of pCm holding a valid manufacturer licence in pCm/Chinese medicine traders transitional certificate (manufacturer licence in pCm). As to whether these pCm manufacturers are Hong Kong-invested pCm manufacturers, since it is not related to safety, quality and efficacy of the pCm, the Department of Health (DH) does not have the relevant information.
The registration system for pCm commenced on December 19, 2003. As at the end of March 2010, CMB received a total of about 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. As at the end of March 2010, CMB already issued a Notice of confirmation of transitional registration of pCm to some 9,120 applications and a Notice of confirmation of (non-transitional) registration application of pCm for some 2,090 applications for non-transitional registration in respect of which three acceptable basic test reports (i.e. acceptable test reports on heavy metals and toxic element, pesticide residues and microbial limit) had been submitted. Some 4,610 applications for registration of pCm were rejected by CMB for failing to furnish basic information for safeguarding public health, information required by CMB, or particulars for registration or for failing to fulfil the definition of a pCm.
The regulation of Chinese medicines by DH aims to safeguard public health. DH does not collect information on the pCm market share of Hong Kong-invested pCm manufacturers.
(b)&(f) All along, DH has been conducting market surveillance on Chinese medicine products (irrespective of whether such products have been registered or not) on a regular basis. If any problem is detected, DH will conduct investigation and take appropriate actions in accordance with the relevant requirements. These include ordering the importers or manufacturers to recall the products in question. Where registered pCm are involved, the cases may be referred to CMB for consideration as to whether the registration of the products should be cancelled, so as to safeguard public health.
In addition, DH has since 2009 carried out post-registration monitoring on pCm. On the basis of risk assessment, samples of pCm which have met the eligibility criteria for transitional registration are collected from the licensed pCm manufacturers and pCm wholesalers for testing. In 2009, it was found that the heavy metal content in three of the 157 pCm samples tested exceeded the set limit. DH conducted investigations immediately and ordered the manufacturers concerned to recall the products from the market and issued press statements. In 2009, a pCm manufacturer found that a batch of its product was contaminated by a western medicine and reported the incident to DH. DH immediately ordered the manufacturer to recall the product from the market and issued a press statement.
Besides, before issuing a manufacturer licence in pCm, DH will conduct inspection to ensure that the relevant premises and facilities meet the requirements of CMB in all aspects. After the issuance of the licence, DH will conduct routine inspection. Investigation or surprise inspection will also be conducted if complaints or referrals are received. During inspection at pCm manufacturers, DH will check whether they have complied with the practising requirements stipulated in the CMO and the Chinese Medicines Regulation and the requirements set out in the practising guidelines issued by CMB. Once any violation of the CMO or the practising guidelines is detected, DH will take enforcement actions and may prosecute the pCm manufacturer concerned. The case will also be referred to CMB for disciplinary actions.
(c) The fee and time needed for testing of the product specification of pCm vary with the prescription ingredients and product specification of each pCm. The product specification of pCm includes description, identification, inspection and assay, involving different testing, testing methods and reference substances, etc. Hence the fee and time needed for product specification testing vary from product to product. The fee of product specification testing will have to be borne by the manufacturers.
(d) In manufacturing pCm, testing has to be conducted by manufacturers on their pCm as to whether they meet the safety and quality standards. Manufactures without the relevant testing facilities or testing capability may commission a testing body to conduct the work on quality control. In addition, establishments performing various testing are required to meet the requirements set by the International Organisation for Standardisation (ISO) or Good Laboratories Practice (GLP), or the testing bodies have to be accepted by CMB. Currently, there are nine local ISO 17025 accredited laboratories and 17 municipal Institutes for Drug Control in Mainland that are recognised by both CMB and the State Food and Drug Administration which provide pCm testing services for the trade.
On the other hand, sharing and briefing sessions with the trade and local laboratories were held by DH and CMB in 2008 and 2009 to enhance their understanding of the specific requirements on the product specification of pCm, testing methods, testing reports and stability testing. The relevant information has been uploaded onto the website of CMCHK for reference by the trade. DH's representatives attend meetings of the Chinese medicines traders from time to time to help the trade understand the requirements for registration of pCm.
The SAR Government and the Hong Kong Jockey Club set up the Hong Kong Jockey Club Institute of Chinese Medicine (ICM) in 2001 to promote, coordinate and strengthen scientific research in Chinese medicines in Hong Kong and facilitate the commercialisation of research results in Chinese medicines. The ICM provides assistance to Hong Kong pCm manufacturers on the safety and quality assessment of Chinese medicine products as follows:
(i) Rendering technical support in various areas such as sourcing and authentication of Chinese medicine raw materials; extraction, isolation and verification of chemical and active ingredients of products; development, establishment and optimisation of the standards and methods for quality control and assessment;
(ii) Providing Hong Kong manufacturers with quality assessment services based on the Chinese Pharmacopeia and the Hong Kong Chinese Materia Medica Standards for their Chinese medicine products; and
(iii) Launching an R&D project specifically focused on the development and production of Chinese medicine chemical markers. At present, about 230 Chinese medicine chemical markers have been made available for the trade.
On the other hand, to cater for the safety test requirements for pCm registration, the Hong Kong Accreditation Service under the Innovative and Technology Commission provides accreditation service for local laboratories under the Hong Kong Laboratory Accreditation Scheme for testing of toxic elements, pesticide residues and microbiological content in pCm. Accreditation has so far been granted to 11 laboratories for testing of pCm.
The Hong Kong Council for Testing and Certification, established by the SAR Government in September 2009, submitted to the Chief Executive a report on the three-year development plan for the testing and certification of the industry in the coming three years in late March this year. The report proposes rendering assistance to open up more business opportunities for the testing and certification industry for Chinese medicines. The Council will collaborate with the Government in the development and regulation of Chinese medicines by, for example, assisting the testing and certification industry to enhance their scale and capability so as to meet the increasing demand for testing services arising from the registration of pCm.
Through the Innovation and Technology Fund (ITF), the SAR Government provides funding support for projects related to Chinese medicine applied research and developing modern technology platforms which have helped equipped local universities and research institutions with advanced equipment to enhance their capabilities in pharmaceutical R&D, pre-clinical study, manufacturing process development, Chinese medicine characterisation and quality assessment, etc. The ITF has also assisted the establishment of:
(i) the Process Development and Manufacturing Facility for Chinese Medicine in the Hong Kong Institute of Biotechnology;
(ii) the Traditional Chinese Medicine Center of the Biotechnology Research Institute at the Hong Kong University of Science and Technology; and
(iii) the Quality Research Laboratory of the Hong Kong Baptist University for analysis and authentication of the ingredients in Chinese herbal medicines.
These facilities can provide the Hong Kong pCm manufacturers with modern equipment of international standard and technical support for the research and development of Chinese medicine products up to international standard.
Since 2005, the Guangdong-Hong Kong Technology Cooperation Funding Scheme has been established under the ITF to encourage closer collaboration between the scientific research institutions and enterprises in Hong Kong and Guangdong Province in Chinese medicine applied research. The Government has all along encouraged enterprises to leverage the knowledge and resources of the universities and scientific research institutions and work together to enhance the innovation, standard of modernised technology and international competitiveness of the Chinese medicine industry.
In addition, the ICM provides support to the R&D of Hong Kong pCm manufacturers in the following ways:
(i) Through its expert network and cooperation with its technology partners, supporting more than 10 different projects including those on R&D of innovative Chinese medicine products, as well as providing pCm manufacturers with the necessary technical support for R&D and contract research services so as to help pCm manufacturers to use modernised methods and scientific technologies to develop high-quality products;
(ii) Through its webpage, publications, market surveys and database etc., disseminating the R&D results and the R&D activities in Hong Kong, the Mainland and overseas and providing information on the regulatory requirements on Chinese medicine products in the major markets and the latest business situation to the industry for reference; and
(iii) Reporting the latest research findings and sharing experience with the industry through organising and participating in seminars and forums related to Chinese medicine.
(e) Pursuant to Section 133 of the CMO, manufacturers holding a pCm manufacturer licence may apply to CMB for a Certificate for Manufacturer (Good Manufacturing Practice in respect of Proprietary Chinese Medicines) (GMP Certificate), certifying that they follow the requirements of good practices in manufacture and quality control of pCm. To facilitate the implementation of quality management, CMB has issued the "Guidelines on Good Manufacturing Practice in respect of Proprietary Chinese Medicines" to provide guidance to pCm manufacturers. The guidelines cover such areas as personnel, factory premises, facilities, documentary records, validation, manufacturing management, quality control, and product recall. However, the GMP system is not a statutory requirement and therefore licensed pCm manufacturers can decide on their own whether it is necessary to apply to CMB for a GMP Certificate. CMB has to date issued seven GMP Certificates. The Government will actively enter into discussion with CMB and the trade to introduce mandatory GMP requirements for manufacturing of pCm as soon as possible.
(g) Chinese medicine has a long history. In the transition from no regulation in the past to implementation of comprehensive regulation, Hong Kong has to draw experience from the Mainland and other places and take into account the local circumstances and the public's demand for traditional pCm. The registration system for pCm is a newly introduced one. While the number of applications received by DH has far exceeded its estimation, there is also a certain degree of complexity in processing individual applications. In addition, in some cases, applicants need to make amendments to or provide supplementary information for their applications in the process. For these reasons, it takes time to process the vetting and grant of approval for the applications.
In light of the progress of processing the applications for pCm registration, the Government has planned to put into full implementation the remaining provisions under the CMO related to mandatory registration of pCm by the end of this year.
Apart from registration of pCm, the Government will ensure the safety of pCm through the following ways:
* Import control will be enforced in accordance with the Import and Export Ordinance. An import licence issued by the Director of Health must be obtained for each consignment of pCm imported into Hong Kong. DH will consider whether the pCm to be imported meet the basic safety requirements before a licence is issued.
* Licensed pCm traders have to observe the law and the requirements of practising guidelines, which include the need to make sure that the pCm manufactured and distributed meet the requirements as to their quality and do not contain any ingredients which are not in the prescription. Besides, there should also be a proper recall system in place to ensure prompt recall of any defective pCm from the market.
* DH will also conduct market surveillance including collection of samples of pCm at retail outlets on a regular basis for testing as well as monitoring cases of adverse drug reactions.
Where any violation of the law of Hong Kong or the practising guidelines for Chinese medicines traders is found, DH will take enforcement actions and may refer the cases concerned to the Department of Justice for consideration of prosecution or to CMB for action.
Note 1: "Proprietary Chinese medicine" means any proprietary product -
(a) composed solely of the following as active ingredients:
(i) any Chinese herbal medicines; or
(ii) any materials of herbal, animal or mineral origin customarily used by the Chinese; or
(iii) any medicines and materials referred to in subparagraphs (i) and (ii) respectively;
(b) formulated in a finished dose form; and
(c) known or claimed to be used for the diagnosis, treatment, prevention or alleviation of any disease or any symptom of a disease in human beings, or for the regulation of the functional states of the human body.
Ends/Wednesday, April 28, 2010
Issued at HKT 12:40
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