Table of Contents

	Acknowledgements
	Acronyms and abbreviations
	Executive summary
	1. Drug regulation: an early concern
		1.1 Historical perspective
		1.2 National drug regulation
		1.3 Global initiatives
	2. Rationale for regulating drugs
	3. Where are we today?
	4. How can drug regulation be made effective?
		4.1 Assess drug regulation performance
		4.2 Identify and develop priority functions
		4.3 Provide a clear mission and purpose
		4.4 Create a supportive environment
		4.5 Formulate adequate drug legislation
		4.6 Create appropriate organizational structure
		4.7 Allocate adequate human and financial resources
		4.8 Minimize corruption and conflict of interest
		4.9 Apply most appropriate strategy
	5. The way forward
	Annex 1. Status of drug regulation and drug quality assurance in WHO African Region and selected countries
	Annex 2. A model framework for assessing drug regulation
	Annex 3. Possible approaches to developing drug regulation ^a
	Annex 4. Examples of mission statements concerning drug regulation
	Annex 5. Fees collected for drug registration
	References

Theme Paper for Discussion - Effective Drug Regulation: What Can Countries Do?, Geneva, 16-19 March 1999

WHO/HTP/EDM/MAC(11)/99.6
Original: English
Distribution: Limited

Geneva
16-19 March 1999

World Health Organization