Effective Drug Regulation - A Multicountry Study and Annex 1: Guide for Data Collection to Assess Drug Regulatory Performance: 1. DRUG REGULATION: OBJECTIVES AND ISSUES: 1.3 OBJECTIVES AND ORGANIZATION OF THIS REPORT

Effective Drug Regulation - A Multicountry Study and Annex 1: Guide for Data Collection to Assess Drug Regulatory Performance
(2002; 187 pages)

Table of Contents

ACRONYMS
PREFACE
ACKNOWLEDGEMENTS
EXECUTIVE SUMMARY
1. DRUG REGULATION: OBJECTIVES AND ISSUES
	1.1 DRUGS AS AN INSTRUMENT OF PUBLIC HEALTH
	1.2 CONTROLLING PRIVATE BEHAVIOUR FOR PUBLIC PURPOSES
	1.3 OBJECTIVES AND ORGANIZATION OF THIS REPORT
2. MULTICOUNTRY STUDY ON EFFECTIVE DRUG REGULATION
	2.1 PROJECT RATIONALE AND DEVELOPMENT
	2.2 STUDY OBJECTIVES
	2.3 METHOD OF STUDY
	2.4 DRUG REGULATION FROM A COMPARATIVE PERSPECTIVE
3. PROFILE OF THE COUNTRIES
	3.1 GENERAL BACKGROUND
	3.2 POLITICAL ENVIRONMENT
	3.3 PHARMACEUTICAL SECTOR ENVIRONMENT
4. REGULATORY FRAMEWORK
	4.1 MISSIONS AND GOALS OF DRUG REGULATION
	4.2 DOMAINS OF CONTROL
	4.3 OTHER NON-REGULATORY PHARMACEUTICAL FUNCTIONS
	4.4 NATIONAL DRUG POLICY
	4.5 HISTORICAL DEVELOPMENT OF DRUG REGULATION
5. REGULATORY CAPACITY
	5.1 LEGAL BASIS, ORGANIZATIONAL STRUCTURE AND AUTHORITY
	5.2 HUMAN RESOURCES
	5.3 FINANCING DRUG REGULATION
	5.4 PLANNING, MONITORING AND EVALUATING IMPLEMENTATION
	5.5 PROBLEMS ENCOUNTERED AND STRENGTHS IDENTIFIED
	5.6 POLITICAL INFLUENCE AND ACCOUNTABILITY
6. LICENSING OF MANUFACTURING, DISTRIBUTION AND RETAIL SALE
	6.1 POWER AND PROCESS
	6.2 HUMAN RESOURCES
	6.3 PAYING FOR LICENSING
	6.4 PERFORMANCE
7. INSPECTION AND SURVEILLANCE
	7.1 POWER AND PROCESS: COMPARING STRUCTURES AND PROCESSES
	7.2 HUMAN RESOURCES
	7.3 PAYING FOR INSPECTION
	7.4 PLANNING, PROCESS AND PERFORMANCE
8. PRODUCT ASSESSMENT AND REGISTRATION
	8.1 POWER AND PROCESS
	8.2 HUMAN RESOURCES
	8.3 PAYING FOR REGISTRATION
	8.4 PERFORMANCE
	8.5 ADVERSE DRUG REACTION MONITORING
	8.6 CLINICAL TRIALS
9. CONTROL OF DRUG PROMOTION AND ADVERTISING
	9.1 POWER AND PROCESS: COMPARING STRUCTURES AND PROCESSES
	9.2 PERFORMANCE
10. DRUG QUALITY CONTROL LABORATORY
	10.1 POWER AND PROCESS
	10.2 HUMAN RESOURCES
	10.3 PAYING FOR QUALITY CONTROL
	10.4 PERFORMANCE
11. ASSESSING REGULATORY PERFORMANCE
	11.1 ASSESSING GOVERNMENT FUNCTIONS: AN ESSENTIAL PART OF POLICY-MAKING
	11.2 MONITORING AND EVALUATION SYSTEM
	11.3 MONITORING AND EVALUATING THE EFFECTIVENESS OF DRUG REGULATION
	11.4 MONITORING AND EVALUATING THE EFFICIENCY OF DRUG REGULATION
	11.5 MONITORING AND EVALUATING THE ACCOUNTABILITY AND TRANSPARENCY OF DRUG regulation
	11.6 AVAILABILITY OF INFORMATION FOR ASSESSMENT
12. CONCLUSIONS AND RECOMMENDATIONS FOR EFFECTIVE DRUG REGULATION
	12.1 CONCLUSIONS RELATED TO REGULATORY STRUCTURES
	12.2 CONCLUSIONS RELATED TO REGULATORY PROCESSES
	12.3 RECOMMENDATIONS FOR EFFECTIVE DRUG REGULATION
ANNEX 1: GUIDE FOR DATA COLLECTION TO ASSESS DRUG REGULATORY PERFORMANCE
	1. Background information
	2. Drug regulation: overview
	3. Regulatory functions
		3.1 Licensing: persons, premises and practices
		3.2 Inspection and surveillance
			3.2.1 GMP inspection
			3.2.2 Inspection of distribution channels
		3.3 Product assessment and registration
		3.4 Adverse drug reaction monitoring
		3.5 Clinical trials
		3.6 Control of drug promotion and advertising
		3.7 Drug quality control laboratory

1.3 OBJECTIVES AND ORGANIZATION OF THIS REPORT

The aim of this report is to compare, contrast and synthesize country experience in drug regulation on the basis of data collected in 1998-1999 in the 10 countries which participated in the WHO multicountry study on effective drug regulation.

While data collected about drug regulation at a fixed point in time are static, drug regulation itself is highly dynamic. Drug regulatory functions are performed in response to a changing environment. This means that the current drug regulation systems in some participating countries may now differ from the system in operation at the time of data collection.

This work does not aim to rank the countries under study against any criteria. Rather, its purpose is to synthesize their experiences and draw generic conclusions from which other countries may learn.

This work does not intend to prescribe ready-made strategies for drug regulation. Instead, it has broader aims, namely to:

• provide simple conceptual frameworks to enhance understanding of the fundamentals of drug regulation, which policy-makers may use in designing drug regulatory systems

• present key features of drug regulatory systems in different countries

• propose drug regulation strategies on the basis of country experiences and the comparative analyses.

Chapter 2 describes the background of the WHO multicountry study, methods of data collection and comparative analysis. Chapter 3 provides a brief profile of each of the countries under study, and compares a number of background features relevant to drug regulation. Conceptual frameworks to be used in the analysis and synthesis of overall drug regulation in subsequent chapters are presented in Chapter 4. In Chapter 5, the authority, capacity and organization of drug regulatory agencies are discussed. Chapters 6-10 address the main drug regulatory functions. Each of these chapters contains parallel sections covering power, process, personnel, financing, regulatory functions and planning and performance. Chapter 11 sets out concepts, methods and indicators for assessing regulatory performance and discusses the performance of the 10 countries in relation to various aspects of regulation. In Chapter 12, key lessons are presented and strategies for improving drug regulation are proposed.