Guidelines for the Appropriate use of Herbal Medicines: References

Guidelines for the Appropriate use of Herbal Medicines
(1998; 88 pages)

Table of Contents

	Foreword
	1. Introduction
		1.1 The role of herbal medicines
		1.2 WHO's policy on herbal medicines
		1.3 The need for the guidelines on appropriate use of herbal medicines
	2. Goals and objectives of the guidelines
		2.1 Goals
		2.2 Objectives
	3. Definitions
	4. National policy development
		4.1 Process for the development of a policy on herbal medicine
		4.2 Issues to be included in the policy
	5. Development of a national programme on herbal medicines
		5.1 National management body for the herbal medicine programme
		5.2 Use of herbal medicines in health care
		5.3 Research on herbal medicines
		5.4 Preparation of information on medicinal plants
		5.5 Conservation of medicinal plants
		5.6 Training and education
		5.7 Collection and exchange of information on herbal medicines
	6. Regulation of practitioners
		6.1 Options
		6.2 Examination
	7. Regulation of the manufacture and distribution of medicinal herbal products
		7.1 General considerations
		7.2 Good manufacturing practices (GMP)
		7.3 Training of regulatory staff
		7.4 WHO certification scheme on the quality of pharmaceutical products moving in international commerce
	8. Regulation of herbal medicines
		8.1 General considerations
		8.2 Requirements for raw plant materials
		8.3 Requirements for processed plant materials
		8.4 Requirements for medicinal herbal products
		8.5 Label requirements
		8.6 Responsible government agency for regulation
		8.7 Promotion and advertisement of herbal medicines
		8.8 Monitoring of adverse reactions to herbal medicines
	9. Use of the guidelines
	Annex 1: Report of the meeting of the working group on herbal medicines
	Annex 2: List of temporary advisers, consultants, observers and secretariat
	Annex 3: Agenda
	Annex 4: Opening Speech of Dr S.T. Han, WHO Regional Director for the Western Pacific Region Working Group on Herbal Medicines, 8 December 1997, Manila, Philippines
	Annex 5: Closing Remarks of Dr S.T. Han, WHO Regional Director for the Western Pacific Working Group on Herbal Medicines, 12 December 1997, Manila, Philippines
	References

References

1. Guidelines for the assessment of herbal medicines, programme on traditional medicine, Geneva: World Health Organization, document, 1991 (WHO/TRM/91.4).

2. Research Guidelines for evaluating the safety and efficacy of herbal medicines, World Health Organization, Regional Office for the Western Pacific, Manila, 1993 (ISBN92 9061 110 3).

3. Guidelines for developing national drug policies, World Health Organization, Geneva, 1988 (ISBN92 4 154230 6).

4. Good manufacturing practices for pharmaceutical products, Annex 1, WHO expert committee on specifications for pharmaceutical preparations, WHO Technical Report Series 823.

5. Good manufacturing practices: supplementary guidelines for the manufacture of herbal medicinal products, Annex 8, WHO expert committee on specifications for pharmaceutical preparations, WHO Technical Report Series 863.

6. Therapeutic Goods Act 1989, Australia.

7. Guidelines for the registration of non-prescription drugs-appendix on herbal products, Therapeutic Goods administration, Commonwealth Department of Health, Housing and Community Services, Australia, December 1991.

8. Guidelines for the classification of dried herbs as therapeutic or nontherapeutic goods, Therapeutic Goods Administration, Commonwealth Department of Health, Housing and Community Services, Australia, September 1991.

9. Guidelines for the application of GMP to the manufacture of herbal medicinal products. Therapeutic Goods Administration, Commonwealth Department of Health, Housing and Community Services, Australia, May 1991.

10. Evidence of standard of overseas manufacturers, Therapeutic Goods Administration, Commonwealth Department of Health, Housing and Community Services, Australia, July 1991.

11. Guidelines to the expression of herbal ingredients in ARTG applications and on labels (herbal ingredient expression guidelines), Therapeutic Goods Administration, Commonwealth Department of Health, Housing and Community Service, Australia, September 1992.

12. Provisions for new drugs approval, Beijing, China: Ministry of Public Health, 1988.

13. Provisions for new drugs approval: supplementary stipulations and revision of issues related to traditional Chinese Medicine, Beijing, China: Ministry of Public Health, 1992.

14. Guiding principles for clinical research on new drugs (traditional Chinese medicine). Beijing China: Bureau of Drug Policy and Administration, Ministry of Public Health, 1989.

15. Quality control methods for medicinal plant material, WHO/PHARM/92.559.

16. ASEAN Good manufacturing practices guidelines, Third edition, 1996.

17. Towards a Safer Choice: the practice of traditional Chinese medicine in Australia, Alan Bensoussan and Stephen P. Myers, Australia, 1996.

18. Report: Regional Workshop on Traditional Medicine, 13-15 November 1995, Hong Kong.

19. Report of the Working Party of Chinese Medicine, Hong Kong, October 1994.

20. Traditional Chinese Medicine: a report by the committee on traditional Chinese medicine, Singapore, October 1995.

21. Anthology of policies, regulations and laws of the People's Republic of China on traditional Chinese Medicine, the State Administration of Traditional Chinese Medicine, China, 1997.