Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines: 2. GENERAL CONSIDERATIONS IN HERBAL MEDICINE RESEARCH: REGULATORY REQUIREMENTS

Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
(1993; 94 pages)

Table of Contents

FOREWORD
1. INTRODUCTION
	BACKGROUND
	GOALS
	OBJECTIVES
	DEFINITION OF TERMS
2. GENERAL CONSIDERATIONS IN HERBAL MEDICINE RESEARCH
	LEGAL CONSIDERATIONS
	ETHICAL CONSIDERATIONS
		RESEARCH ON HUMAN SUBJECTS
		RESEARCH ON ANIMALS
		RESPECT FOR THE ENVIRONMENT
	TRADITIONAL KNOWLEDGE ON HERBAL MEDICINE
	REGULATORY REQUIREMENTS
	PURPOSES OF RESEARCH
	SELECTION OF RESEARCH PROJECTS
	RESEARCH APPROACHES
	ASSURING ACCESS TO RELEVANT DATABASES
	EDUCATION
3. RESEARCH STUDIES
	LITERATURE BACKGROUND
	PROTOCOL PREPARATION
	QUALITY SPECIFICATIONS OF PLANT MATERIALS AND PREPARATION
	NON-CLINICAL STUDIES
		PHARMACODYNAMIC INVESTIGATIONS
		GENERAL PHARMACOLOGICAL INVESTIGATIONS
		TOXICOLOGICAL INVESTIGATIONS
		METHODS
	CLINICAL TRIALS USING HERBAL MEDICINES
		CLINICAL TRIAL PROTOCOL DEVELOPMENT
		PHASES OF A CLINICAL TRIAL
		ETHICS REVIEW BOARD
		RESPONSIBILITIES OF INVESTIGATORS
		RESPONSIBILITIES OF THE SPONSOR
		DATA MANAGEMENT
		STATISTICAL ANALYSIS
		REPORTING
	EVALUATION OF HERBAL MEDICINE RESEARCH
	TECHNOLOGY TRANSFER AND EDUCATION
		HERBAL MEDICAL RESEARCH
		THE HEALTH CARE PROFESSIONS
		THE PUBLIC
4. USING THE GUIDELINES
	A. GUIDELINES FOR QUALITY SPECIFICATIONS OF PLANT MATERIALS AND PREPARATIONS
		INFORMATION FOR FRESH, DRIED AND PROCESSED PLANT MATERIALS
		INFORMATION FOR MEDICINAL PREPARATIONS OF PLANT MATERIALS
	B. GUIDELINES FOR PHARMACODYNAMIC AND GENERAL PHARMACOLOGICAL STUDIES OF HERBAL MEDICINES
		ANIMALS
		ADMINISTRATION
	C. GUIDELINES FOR TOXICITY INVESTIGATION OF HERBAL MEDICINES
		ACUTE TOXICITY TEST
		LONG-TERM TOXICITY TEST
		LOCAL TOXICITY TEST
		SPECIAL TOXICITY TESTS
ANNEXES
	ANNEX 1. WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI*
	ANNEX 2. REPORT OF THE MEETING OF THE WORKING GROUP ON THE SAFETY AND EFFICACY OF HERBAL MEDICINE (MANILA, 5 - 9 OCTOBER 1992)
	ANNEX 3. LIST OF MEMBERS, CONSULTANTS AND SECRETARIAT
NOTES
BIBLIOGRAPHY
SELECTED WHO PUBLICATIONS OF RELATED INTEREST

REGULATORY REQUIREMENTS

Regulatory requirements may be different in different countries As a general rule, traditional experience which means that long-term use as well as the medical, historical and ethnological background are well recorded, should be taken into account WHO Guidelines for the Assessment of Herbal Medicine* should be consulted for the registration of herbal medicine products

* Guidelines for the assessment of herbal medicine programme on traditional medicine Geneva World Health Organization, document, 1991 (WHO/TRM/91,4)

In the design and conduct of researches on herbal medicine, the country’s regulatory requirements must already be considered, particularly those required for registration of herbal medicine products.