2013年9月7日星期六

Seminar on Research and Development of Chinese Medicines

The two-day Seminar on Research and Development of Chinese Medicines was organized by the Committee on Research and Development of Chinese Medicines on 5 and 6 September 2013. The seminar was co-organized with the Department of Health, the Hospital Authority, and the Hong Kong Council for Testing and Certification. It aimed to share experience in R&D of Chinese medicines and facilitating communication among stakeholders in the Chinese Medicine sector.

The Committee was set up by HKSAR Government in December 2011 to act as a platform to gauge views from various stakeholders in Hong Kong, so as to formulate the broad direction in promoting research and development (R&D) of Chinese medicines, and to facilitate sharing of R&D outcome and enhance collaboration among parties concerned.


Ms. Wong Wing-chen, Janet (Chairperson of Committee on Research and Development of Chinese Medicines; and Commissioner for Innovation and Technology, HKSAR Government) gave a Welcoming Remarks. She briefed the Committee’s work in the past.


Dr. Chan Hon-yee, Constance (Director of Health, HKSAR Government) gave us a briefing about the development of Chinese Medicine Standards and GMP implementation status.


Dr. Cheung Wai-lun, Allen (Director (Cluster Services), Hospital Authority) introduced there were 17 Chinese Medicine (CM) outpatient services and expected to be one more outpatient services soon that a CM outpatient service in each district.


Group photo of all guests and speakers


The first speaker was Dr. Ko Wing-man (Secretary for Food and Health, HKSAR Government) and his topic entitled "The Development of Chinese Medicine (CM) in Hong Kong". Dr. Ko briefed the history of CAP 549 CHINESE MEDICINE ORDINANCE which established since 1999. Unit April 2013, there were 6,561 registered Chinese medicine practitioner. The output of CM industry had increase about 12.6% from 2008 to 2010.


In order to promote CM industry, the standards of CM had developed since 2002. There were about 200 types of CM standards established. The Committee aimed to promote CM standard globally, establishing the reputation of CM and upgrading the CM production quality level.


The second speaker was Prof. Huang Lu-qi (Deputy Director General of the Department of Science and Technology, State Administration of Traditional Chinese Medicine) and his presentation named "Research on the Sustainability of Chinese Medicines Resources in China". Firstly, Prof Huang introduced the regulation of China Food and Drug Administration (CFDA) - "Drug Registration" (Board Order No. 28) 《药品注册管理办法》(局令第28号). Since many CMs were exhausted, some artificial CM substitutes were developed and patented in China. The survey of CM types in China had performed since 1983 and reviewed every 5 years. There were 12,807 types of CM and only about 200 type of CM could be incubated


Prof. Huang introduced Sustainability of Chinese Medicines Resources policies as follows.
1. To develop technology which transferred the natural growth CM into incubated CM.
2. To find substitute for some extinction types of CM.

The third speaker was Prof. Lao Li-xing (Director, School of Chinese Medicine, The University of Hong Kong (HKU)) and his presentation topic was "Latest R&D Trend in Chinese Medicine". Prof. Lao said Chinese Herb Medicine trials were rarely funded in the West compared with Herb. However, all clinical studies conducted in China on Chinese Herbal Medicine (CHM) had been positive.


The problem was found that the methodological quality of most CHM trials was low. It was because the cultural differences between West and East. TCM theories such as Yin-Yand and five-element theory were not easily understood or accepted by Western medical community. Another barrier was safety concern. The following table identified the differences.


Then Prof. Lao compared the Western Drug Development and Chinese Herbal Research and summarized as the following table. Finally, Prof Lao concluded to use rigorous scientific research methodology that preserved the essence of TCM practice.


Dr. Heiner Grueninger (Global Program Head for Tropical Medicines, Novartis) was the fourth speaker and his topic named "Commercialisation of R&D: Coartem, Taking a TCM from Laboratory to Regulatory Approval". Dr. Grueninger introduced the prevention and treatment of Malaria and today's standard malaria treatment named "Artemisinin Combination Therapy (ACTs)" was discussed. ACTs had 95% cure rate against faciparum malaria. Then he introduced the 3 development steps of Coartem dispersible tablets from Children to Adult healthy volunteers and finally to Children with malaria.


Mr. Tsang Kam-lam (General Manager, Environmental Management Divsiion, Hong Kong Productivity Council) was the last speaker in the morning session and his presentation entitled "Product Certification Scheme for Chinese Materia Medica". Mr. Tsang introduced Chinese Materia Medica (CMM) Certification, its requirement and benefit of the scheme.


HKPC established a Product Certification Scheme (PCS) for CMM which initiated by CM Panel of HKCTC and funded by ITF and sponsored by CM trades. CMM Certification is a voluntargy programme in Hong Kong. The certification process included management audit, documents & records audit, sampling, testing, provide product in compliance with the standard requirement. The following diagram showed PCS development and Subsequent Implementation.


The certification scheme would certify the CMM in Hong Kong Standard for Chinese Materia Medica (HKSCMM) and the Pharmacopoeia of The People's Republic of China. The scheme requirement included quality management and product requirement (e.g. CMM identification, Assay of CMM and Contaminants).

Panel Discussion: Promoting the Development of Chinese Medicines
(Panelists started from Left)
Dr. Pang Wai-bing, Cecilia (Biotechnology Director, Innovation and Technology Commission, HKSAR Government)
Dr. Ronald Lam (Assistant Director (Traditional Chinese Medicine), Department of Health, HKSAR Government) and he said the Committee was a platform to promote CM.
Dr. Lawerence Lai (Convener of the Panel on Promoting Testing and Certification Services in Chinese Medicines Trade of the Hong Kong Council for Testing and Certification) and he said Hong Kong had advantage to promote CM testing and certification because of good accreditation system.
Ir. T.B. Yeung, Allen (Vice President, Business Development and Technology Support, Hong Kong Science & Technology Parks Corporation) and he said that there were nine CM companies performed R&D in Science Park. The holistic support flow was R&D in Science Park, Production in Industrial Estate and Brand building in InnoCentre.


Reference:The Committee on Research and Development of Chinese Medicines - http://www.info.gov.hk/gia/general/201301/17/P201301170520.htm
Seminar on Research and Development of Chinese Medicines - Present and Future - http://www.itc.gov.hk/en/area/act.htm
Department of Health - http://www.dh.gov.hk/eindex.html
Hospital Authority - http://www.ha.org.hk/visitor/
HKCTC: http://www.itc.gov.hk/en/hkctc/about.htm


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