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CONTENTS
Foreword vii
1. Introduction 1
1.1 The role of herbal medicines 1 1.2 WHO's policy on herbal medicines 1 1.3 The need for the guidelines on the appropriate 3 use of herbal medicines 2. Goals and objectives of the guidelines 5 2.1 Goals 5 2.2 Objectives 5
3. Definitions 6
4. National policy development 9 4.1 Process for the development of a policy 9 for herbal medicine 4.2 Issues to be included in the policy 10
5. Development of a national programme 14
on herbal medicines 5.1 National management body for the herbal 14
medicine programme 5.2 Use of herbal medicines in health care 15
5.3 Research on herbal medicines 16
5.4 Preparation of information on medicinal plants 16
5.5 Conservation of medicinal plants 17
5.6 Training and education 18 5.7 Collection and exchange of information 18
on herbal medicines
6. Regulation of practitioners 19
6.1 Options 19
6.2 Examination 19
7. Regulation on the manufacture and distribution 21 of medicinal herbal products
7.1 General considerations 21
7.2 Good manufacturing practices (GMP) 22
7.3 Training of regulatory staff 22
7.4 WHO certification scheme on the quality 23 of pharmaceutical products moving
in international commerce
8. Regulation of herbal medicines 24
8.1 General considerations 24
8.2 Requirements for raw plant materials 27 8.3 Requirements for processed plant materials 28 8.4 Requirements for medicinal herbal products 29
8.5 Label requirements 32
8.6 Responsible government agency for regulation 33 8.7 Promotion and advertisement of herbal 34
medicines
8.8 Monitoring of adverse reactions to herbal 34 medicines
9. Use of the guidelines 35
Annexes 36
1 Report of the meeting of the working group 36 on herbal medicines
2 List of temporary advisers, consultants 62 observers and secretariat
3 Agenda 69
4 Opening Speech of Dr S.T Han 71
WHO Regional Director of the Western Pacific Region working Group on Herbal Medicines, 8 December 1997
Manila, Philippines
5 Closing Remarks of Dr S.T. Han, 74
WHO Regional Director of the Western Pacific Region Working Group on Herbal Medicines, 12 December 1997,
Manila, Philippines
References 76
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