... 3... 10... 12... 13 3.1... 13 3.2... 13 3.3... 14 3.4... 15 3.5... 17 3.6... 21 3.7... 23 3.8 GMP... 24 3.9... 26... 28 4.1... 28 4.2... 29... 30 5.1... 30 5.2.... 30 5.3... 37 5.4... 38 5.5... 39 5.6... 40 5.7... 41 5.8... 42... 44... 46 1
... 48 8.1... 48 8.2... 49 8.3... 49 8.4... 50 8.5... 50 8.6 GMP... 51 8.7... 51 8.8... 52 8.9... 53... 54... 55 2
. 1997. 1. 2. 3. 4. 5.. 1. 2. 3. 4. 5. 6. 7. 8. 3
. 1. 2. 3. GMP 4. 5. 6.. 1. 4
2 2.1 GMP ( ) 2.2 2.3 3 ( ) 5
4 4.1 4.2 ( ) 5 6 GMP GMP GMP GMP 6
GMP GMP GMP GMP GMP GMP GMP GMP GMP GMP GMP GMP 7 7.1 3 7.2 7.3 7
7.4 8 8.1 8.2 8.3 8
8.4 9 9.1 9.2. 9
1997 1999 50 10
11
12
3.1 2013 3 8 861 4480 295 1067 2010 1873 19.3 2010 1806 10.4 2010 1395 3.9 2010 4824 18 2010 50 2010 ( ) 20.4 8.6 2011 ( ) 15.2% 23.5 10% 9.5 2011 26% (21.1%) (13.7%) (12.9%) (9.8%) ( ) (23.7%) (14.5%) (12.6%) (10.3%) (10.2%) 3.2 1920 1930 1970 13
3.3 1841 1942 1978 1997 1999 7 ( 549 ) ( ) 2003 2008 14
3.4 138 138 1999 ( ) ( ) 2002 3.4.1 I. ( ) ( 3.5 ) II. III. 1 2 31 574 15
IV. V. VI. 2000 1 3 3.4.2 I. II. ( ) 16
III. ( ) 3.4.3 I. ( 60 ) II. ( 132 ) III. ( ) ( 187 ) IV. ( 231 ) V. ( 354 ) VI. ( 362 ) VII. ( 201 ) VIII. ( 138 ) 3.5 ( ) 17
行政長官 管委會 食物及衛生局 商務及經濟發展局 中藥組 中醫中藥發展委員會 創新科技署 衛生署 政府化驗所 漁農自然護理署 中藥研究及發展委員會 中醫藥事務部 中藥組 3.5.1 ( ) 1999 1 2 18
管委會 中藥組 中藥管理小組 中藥業管理小組 中藥業監管小組 1 2 3.5.2 衛生署 ( 衛生署署長領導 ) 中醫藥事務部 ( 助理衛生署署長領導 ) 19
(GMP) 3.5.3 政府化驗所 中藥組 1998 3.5.4 ( ) 187 ( ) 3.5.5 2000 20
3.5.6 2011 12 4 3.5.7 2013 2013 3 4 3.6 3.6.1 I. 1999 50 70 2 21
( ) II. 2010 30% 3.6.2 I. 4 (a) 50% (b) ( ) 80% (c) (d) II. 2 (a) 2012 5 31 2014 2 28 (b) 22
3.7 3.7.1 I. 3 20 22 2014 2016 10 75 6 67 6 II. ( ) 1988 (GMP) III. 1967 23
IV. 2009 V. 3.7.2 ( ) ( ) ( ) 3.8 GMP 2002 GMP( ) GMP 1975 GMP ( ) GMP GMP GMP 24
GMP GMP 2010-2011 GMP GMP GMP 2011 5 (PIC/S) GMP GMP GMP GMP GMP 25
GMP GMP GMP 2013 3 295 11 GMP 3.9 2009 26
2002 2012 12 5 140 27
4.1 4.1.1 4.1.2 4.1.3 132 28
4.1.4 4.2 2009 2010 91 78 2012 11 914 45 2013 1 9 93 2012 49 29
5.1 600 Global Industry Analysts 2017 1070 IMS Institute for Healthcare Informatics The Global Use of Medicines: Outlook Through 2016 2011 9560 34% 24% 12% 7% 2016 1.2 2000 2050 60 11% 22% 6 5 20 5.2. 5.2.1 I. 13 9 74 77 60 13% 2011 8,390 432 5.2% 30
2012 842 31.24% 33.72 24.99 8.73 II. ( ) A. B. C. D. E. F. 國家食品藥品監督管理總局 藥品化妝品註冊管理司 藥品化妝品監管司 食品安全監管司 藥品審評中心 中國食品藥品檢定研究院 國家藥典委員會 GMP 31
III. 20 1996 2000 2002 1995 2002 (GMP) GMP GMP 1975 GMP 1988 GMP 1995 GMP 1998 2004 7 1 GMP (GLP) GLP GLP GLP GLP 1999 32
GLP GLP (GCP) GCP 1992 GCP 1993 GCP GCP 1995 GCP 1999 GCP GCP (GAP) GAP 2002 GAP GAP (GEP) GEP 2002 GEP 2007 (2006-2020 ) ( ) 2009 33
2011 34 5.2.2 I. 2 3 76 83 2011 17,758 2009 1,133 6.9% 2010 1 1 7 2011 45 25 2.5 II. 1970 ( 39 ) ( ) 34
1982 GMP GMP III. 1970 4 1980 1995 2013 2013 2016 35
5.2.3 I. 58 82.4 65 7.7% 5 8 2011 4.7 II. (a) (b) (c) (d) 1994 53/94/M (GMP) 36
III. 2003 2011 2013 5.3 5.3.1 3 2 4 9 76 81 2011 8 6 GDP 18% 60 19% 18 1972 Nutrition Business Journal 2003 42 2007 47 2011 53 5.3.2 (U.S. Food and Drug Administration FDA ) FDA FDA FDA FDA FDA 37
FDA FDA FDA 8 (GMP) FDA FDA GMP FDA 5.4 5.4.1 5 65 17.5% 3 5 100 38
5.4.2 1995 (ENEA) 2001 2004 1. 30 15 30 2. GMP 3. 4. 5.5 5.5.1 1 3 3 5 79 86 2011 3 2 GDP 9.3% 60 32% 5 2 3 39
5.5.2 2 5.5.3 1976 1989 2 5.6 5.6.1 4 9 3 77 84 2011 2 2 GDP 7.2% 60 16% 2 2 20 80 40
5.6.2 200 5.6.3 1993 72% 70 5.7 5.7.1 5 9 80 85 2011 2,800 GDP 4.6% 60 15% 14 1965 5.7.2 41
5.7.3 40 2,000 3,000 2011 1,400 95% 90% 5.8 42
43
1842 1997 力 44
45
1,100 25% GMP GMP GMP GMP GMP GMP 300 11 GMP GMP 46
47
8.1 48
8.2 8.2.1 GMP ( ) 8.2.2 8.2.3 8.3 ( ) 49
8.4 8.4.1 8.4.2 ( ) 8.5 50
8.6 GMP GMP GMP GMP GMP GMP GMP GMP GMP GMP GMP GMP GMP GMP GMP GMP 8.7 8.7.1 3 8.7.2 8.7.3 51
8.7.4 8.8 8.8.1 8.8.2 8.8.3 52
8.8.4 8.9 8.9.1 8.9.2 53
54
1. 2010 2 2. 2008 11 3. IN07/10-11 2011 2 14 4. http://www.cccmhpie.org.cn/ 5. http://www.censtatd.gov.hk/home/index_tc.jsp 6. Nutrition Business Journal www.nutritionbusiness.com 7. http://www.miit.gov.cn/n11293472/index.html 8. http://www.cccmhpie.org.cn/ 9. http://www.satcm.gov.cn/zhuanti/zyyfuwumaoyi/2012-06-26/15809.html 10. http://www2.itis.org.tw/netreport/netreport_detail.aspx?rpno=407441230 11. http://hdais.coa.gov.tw/htmlarea_file/web_articles/hdais/1981/2011_01.pdf 12. http://www.mohw.gov.tw/cht/ministry/unit.aspx?f_list_no=4 13. http://big5.taiwan.cn/gate/big5/www.taiwan.cn/lshshj/whlshshj/xlbm/20030 7/t20030730_110908.htm 14. http://www.cmchk.org.hk/pcm/chi/#main_index.htm 15. http://www.basiclaw.gov.hk/tc/basiclawtext/index.html 16. 1997 http://www.policyaddress.gov.hk/pa97/chinese/pa97_c.htm 17. 2010-2011 http://www.policyaddress.gov.hk/10-11/ 18. 2013 http://www.policyaddress.gov.hk/2013/chi/index.html 55
19. 2013-2014 http://www.budget.gov.hk/2013/chi/speech.html 20. http://www.legco.gov.hk/cindex.html 21. http://www.hkctc.gov.hk/tc/pst_c_medicine_c.html#4 22. http://www.tid.gov.hk/cindex.html 23. http://www.hkmc.com.hk/chi/ops/ourbusiness/sme.html 24. http://www.cedd.gov.hk/tc/index.htm 25. http://data.worldbank.org/indicator/gb.xpd.rsdv.gd.zs 26. http://research.hktdc.com/tc/ 27. IMS Institute for Healthcare Informatics http://www.imshealth.com/portal/site/ims/menuitem.5ad1c081663fdf9b41d84 b903208c22a/?vgnextoid=e39f79d7f269e210vgnvcm10000071812ca2rcrd 28. IMS Institute for Healthcare Informatics, The Global Use of Medicines: Outlook Through 2016, July 2012 http://www.imshealth.com/deployedfiles/ims/global/content/insights/ims %20Institute%20for%20Healthcare%20Informatics/Global%20Use%20of%20Med s%202011/medicines_outlook_through_2016_report.pdf 29. Global Industry Analysts, Inc. http://www.strategyr.com/default.asp 30. http://www.who.int/medicines/publications/en/ 31. http://portal.gov.mo/web/guest/aboutmacao 56