- P-ISSN 1010-0695
- E-ISSN 2288-3339
- Apply for Authority
- P-ISSN1010-0695
- E-ISSN2288-3339
Article Detail
Home > Article Detail
Suggestion about Modernized Classification of Herbal Medicinal Preparations in Dual Medical Systems
Journal of Korean Medicine / Journal of Korean Medicine, (P)1010-0695; (E)2288-3339
2015, v.36 no.1, pp.61-74
&
(2015). Suggestion about Modernized Classification of Herbal Medicinal Preparations in Dual Medical Systems. Journal of Korean Medicine, 36(1), 61-74.
- Downloaded
- Viewed
Abstract
Objectives: The main purpose of this study is to find a solution for modernized classification of herbal medicinal preparations in dual medical systems. Through this study, we expect to provide a reasonable foundation of herbal medicine for public health. Methods: We studied legal or technical terms of herbal medicinal preparations from the past regulations, and through this procedure, we could suggest clear definitions of terms for herbal medicinal preparations. We also investigated documents for approval of herbal medicinal preparation from US, EU(European union), The People's Republic of China, Japan, so that we can refer to them to revise regulation for appropriate use of herbal preparations. Results: In Korea pharmaceutical affairs act, any basis of ‘Crude drugs’ does not exist. But in some subordinary notifications, the way that they use the 'Natural product medicine' is used as a means of limiting basic rights of doctor or pharmacist of Korean medicine compared to doctor or pharmacist. At the same time, in subordinary notifications, provisions are vague and not enough for scientific evidence of Korean medicine. Thus, we re-categorized herbal medicinal preparations into new drugs, drugs made from herbal medicinal preparations and suggested requirements for drug approval. Conclusions: Instead of using the term ‘Crude drug preparations’, and we should use term ‘Herbal medicinal preparations’ in related act and notification. And also we suggest to amend subordinary regulations and documents for approval of herbal medicinal preparations. Through this, we can make herbal medicinal preparations be more industrialized.
- keywords
- Pharmaceutical affairs act, Crude drug preparations, Herbal medicinal preparation, Herbal Medicine
Reference
1
1. Ministry of Health and Welfare. Medical Service Act. Act No. 10609, 28. Apr, 2011., Partial Amendment.
2
2. Ministry of Health and Welfare. Pharmaceutical Affairs Act. Act No. 12450, 18. Mar, 2014., Partial Amendment.
3
3. Yin CS, Lee SW, Kim YK. How to establish the definition of Conventional medicine and Korean herbal medicine?. Formula Science. 2012;20(2): 187-197.
4
4. Eom SK, Kim SH, Kim KS, Park SJ, Eo WK, Choi WC. A Proposal for Research Process of Botanical Drug based Clinical Traditional Korean Medicine; Historical Evidence-Based Medicine Ⅱ. J. Oriental Medical Classics. 2010;23(4):63-102.
5
5. National Institute of Food and Drug Safety Evaluation. Reports about the Standardization of Herbal Medicine Preparations in Korea. 2012.
6
6. Kim YK, Cho SY, Kim JY, Kang YS. Semantic Change of Crude Drug Preparations in Korea and Policy Evaluation. Herbal Formula Science. 2013;21(2):29-43.
7
7. Kang EH. 10 years' evaluation and 10 years' henceforward prospect of Korean medicine and pharmaceuticals Ⅱ. 2009. Available at: URL:http: //www.mjmedi.com/news/articleView.html?idxno=16534. Accessed May 8, 2009.
8
8. Ministry of Food and Drug Safety. Food and Drug Statistical Year Book. 2010. Available at: URL:http://www.mfds.go.kr/index.do?mid =690&seq=9322&cmd=v.
9
9. Pusan National University School of Korean Medicine, Korea Institute of Oriental Medicine, Association of Korean Medicine. 2012 Year Book of Traditional Korean Medicine. 2013.
10
10. Ministry of Health and Welfare. Act on the Promotion of Natural Product Drug Research and Development. Act No. 12844, 19. Nov, 2014., Other Laws and Regulations Amended.
11
11. Ministry of Food and Drug Safety. Regulation on Pharmaceuticals Approval, Notification and Review. Notification No. 2008-56, 14. Aug, 2008.
12
12. Ministry of Food and Drug Safety. Regulation on Herbal Medicinal Preparations(Crude Drugs) Approval and Notification. Notification No. 2011-22, 30. May, 2011., Enactment.
13
13. Ministry of Food and Drug Safety. Regulation on Herbal Medicinal Preparations(Crude Drugs) Approval and Notification. Notification No. 2014-100, 3. Mar, 2014., Partial Amendment.
14
14. Society for Medicinal Plant and Natural Product Research. Aims of the Society for Medicinal Plant and Natural Product Research. Available at: URL:http://www.ga-online.org/about_more_ en.htm.
15
15. Korea Institute of Oriental Medicine. Japanese Herbal Medicine Market Production Status. 2010. Available at: URL:http://kiom.e-eyagi. com/newsletter/2009/0701/report.pdf.
16
16. Ministry of Health and Welfare. Act on the Promotion of Korean Medicine and Pharmaceuticals. Act No. 11524, 22. Oct, 2012., Partial Amendment.
17
17. Food and Drug Administration. Guidance for Industry, Botanical Drug Product. 2004. Available at: URL:http://www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ucm070491.pdf.
18
18. European Union. Directive 2004/24/EC of the European Parliament and of the Council. 2005. Available at: URL:http://ec.europa.eu/health/d ocuments/eudralex/vol-1/index_en.htm#dir.
19
19. Kim CW. Korean 'Natural Product Drug' and Chinese Medicine. The Minjok Medicine News Special Contribution. 2012. Available at: URL:http://www.mjmedi.com/news/article View.html?idxno=23213.26. Accessed Jul, 2012
20
20. Thomas B, Ldenzil P, Stefan S. Classification of Herbal(Medicinal) Products. In: A Practical Guide to Licensing Herbal Medicinal Products. London:Pharmaceutical Press. 2010:1-17.
21
21. The People's Republic of China. Drug Administration Law. 10. Jul, 2007.
22
22. Seoul Administrative Court. 2012Guhap421991, Verdict of Notification Invalid Confirmation Litigation. 9. Jan, 2014.
23
23. Ministry of Food and Drug Safety. Regulation on Herbal Medicinal Preparations(Crude Drugs) Approval and Notification. Notification No. 2012-22, 22. May, 2012., Partial Amendment.
24
24. Ministry of Food and Drug Safety. The Korean Herbal Pharmacopoeia. Notification No. 2014-74, 12. Feb, 2014., Partial Amendment.
25
25. National Drug Regulatory State, The People's Republic of China. Technical Requirements of Chinese Drug Research. 1999.
26
26. Ministry of Food and Drug Safety. Reports about Study on Foreign Regulatory Affairs of Medicinal Plants and Botanical Drug Products. 2005.
- Downloaded
- Viewed
- 0KCI Citations
- 0WOS Citations
Other articles from this issue
- Clinical Practice Guideline on Acupuncture for Post-stroke Spasticity
- Effects of topical application of realgar on pruritus and inflammation of atopic dermatitis
- The Effect of Gamisoyo-san Intravenous Pharmacopuncture on Restoration of Liver Function after Partial Hepatectomy in SD Rat
- Herbal-drug-associated Adverse Events Reported in the Internet Newspaper Articles
- Analysis of Herbal-drug-associated Adverse Drug Reactions Using Data from Spontaneous Reporting System in Electronic Medical Records
- Suggestion about Modernized Classification of Herbal Medicinal Preparations in Dual Medical Systems
- The effects of Atractylodes japonica Koidz. on type 2 diabetic rats
- A Case Report on Two Psoriasis Patients with Insomnia
- more
Recommanded Articles
This website recommended the use the Chrome browser for journal website.