Replies to LegCo questions
LCQ15: Regulation on Chinese medicine
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
------------------------------------------
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
-------------------
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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