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香港的中醫藥 CM development in HK

香港的中醫藥 CM development in HK. 兩地中醫藥的科技和經貿合作 (Business and technology collaboration) 特色和優勢 (Hong Kong Advantages) 中醫藥業的特點 (Industry specifics) 中醫藥 規管 (CM regulations) 中醫藥 的法例 和標準 (Standards). HKJCICM. HKJCICM. HKJCICM. HKJCICM. HKJCICM.

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香港的中醫藥 CM development in HK

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  1. 香港的中醫藥 CM development in HK • 兩地中醫藥的科技和經貿合作 (Business and technology collaboration) • 特色和優勢 (Hong Kong Advantages) • 中醫藥業的特點 (Industry specifics) • 中醫藥規管 (CM regulations) • 中醫藥的法例和標準 (Standards) HKJCICM

  2. HKJCICM

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  6. Structure of the Regulatory Body in Hong Kong 規管組織的架構 Chinese Medicine Council 香港中醫藥管理委員會 Chinese Medicine Practitioners Board 中醫組 Chinese Medicines Board 中藥組 Chinese Medicines Committee 中藥管理小組 Chinese Medicines Traders Committee 中藥業管理小組 Disciplinary Committee 中藥業監管小組 Registration Committee 註冊事務小組 Examination Committee 考試小組 Disciplinary Committee 紀律小組 Committee on Assessment of Chinese Medicine Degree Courses 中醫學位課程小組 HKJCICM

  7. Chinese Medicine Practitioners in HK 中醫師 • 5,850 registered CMPs, and 2,824 listed CMPs (updated: 02/10/2008) 5,850 註冊中醫師及2,824表列中醫師 • “limited registration” to facilitate the engagement of overseas or Mainland Chinese medicine experts 有限制註冊以提供海內外中醫專家作教學或研究 HKJCICM

  8. Licensed Chinese medicines traders in HK 持牌中藥 商 (Last Updated: 31 October 2008) HKJCICM

  9. Proprietary Chinese medicines 中成藥 • About 16,000 applications for registration of proprietary Chinese medicines (pCms) 大約有16,000種中成藥需要註冊 • The Medicines Board shall, in determining an application for pCm registration, take into consideration the safety, quality and efficacy of the product 香港中醫藥管理委員會會考慮產品的安全性、質量及成效作為申請註冊的條件 HKJCICM

  10. Regulation of pCm in HK中成藥的規管 • Pre-marketing approval - registration 上市前審批-中成藥註冊 • Post-marketing Adverse Reaction Reporting 不良反應通報 • Import and Export control 出入口管制 • Record keeping 保存完整紀錄 • Complaint and Recall System 投訴及回收系統 HKJCICM

  11. Other legal requirements有關法例 • Chinese Medicine Ordinance (Cap.549) 《中醫藥條例 》香港法例第549章 • Import and Export (General) Ordinance (Cap.60) 《 進出口條例 》香港法例第60章 • Undesirable Medical Advertisements Ordinance (Cap.231) 《不良醫藥廣告條例 》香港法例第231章 • Trade Marks Ordinance (Cap.43) 《商標條例》香港法例第43章 • Trade Description Ordinance (Cap.362) 《 商品說明條例》香港法例第362章 • Animal & Plants (Protection of Endangered Species) Ordinance (Cap.187) 《動植物(瀕危物種保護)條例》香港法例第187章 • Pharmacy and Poisons Ordinance (Cap.138) 《藥劑業及毒藥條例》香港法例第138章 • Public Health and Municipal Services Ordinance (Cap.132) 《公眾衛生及市政條例》香港法例第132章 HKJCICM

  12. Hong Kong Chinese Materia Medica Standards 香港中藥材標準 • Launched in 2002 by the Department of Health 衛生署於2002啟動 • Provide recommendations and references regarding the quality and safety aspects of 60 commonly used Chinese herbal medicines in Hong Kong 提供60種香港常用中藥材的對照 • The HKCMMS (Volume One) covering 8 Chinese herbal medicines was published in July 2005 第一冊包括8種藥材已於2005年7月發表 • The HKCMMS (Volume One) covering 24 Chinese herbal medicines was published in Sep 2008 第二冊包括24種藥材已於2008年9月發表 (www.info.gov.hk/dh) HKJCICM

  13. 香港中藥相關研究架構 Infrastructure in HK HKSAR Government 特區政府 中醫藥條例 創新科技咨詢委員會 創新科技署 香港應用科技研究院 (ASTRI) 香港賽馬會中藥研究院 (HKJCICM) 信息技術 Bio-informatics 中藥 Chinese medicine 生物技術 Biotechnology … R&D Facilities 科研設施 香港科技園區 9家全日制大學 2家教學醫學院 香港生物科技研究院 R&D Resources 科研經費來源 大學撥款委員會 創新科技基金 健康服務研究基金 慈善基金 HKJCICM

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  16. Briefing of HKJCICM • Established under ITC of HKSAR Government in 2001 as strategic development platform and Chinese Medicine R&D Centre • HKJCICM: one of six R&D centers • Supported by the Hong Kong Jockey Club Charity Trusts - pledged donation of HK$500 million (US$64 million) • Mission - To spearhead the advancement of CM and the industry through quality, science, evidence and application HKJCICM

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  23. CMED HKJCICM

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  25. HKJCICM Project Overview New Drug Development QC Info. exchange HKJCICM

  26. 項目概覽 中藥新藥研發 加強中藥的質控 資訊交流 HKJCICM

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  33. Opportunity for collaboration in CM 合作 產品開發 (product development) 海外市場拓展及註冊 (market development & registration support) 中醫藥研發項目合作 (R&D collaboration) 中藥材品質控制 (QC) 中藥化學對照品 (QC -Chemical markers) 中醫藥領域人才交流 (education & exchanges) 資訊交流 (information) 國際會議及展覽會 … (conference) … * Health & wellness: Promoting the tradition, education, raising public awareness * Strengthening partnership: “Government – academia – industry – investment” * Application of R&D deliverables: business development networks & TT platforms HKJCICM

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