Effective Drug Regulation - A Multicountry Study and Annex 1: Guide for Data Collection to Assess Drug Regulatory Performance: 6. LICENSING OF MANUFACTURING, DISTRIBUTION AND RETAIL SALE

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

6. LICENSING OF MANUFACTURING, DISTRIBUTION AND RETAIL SALE

Specifications regarding pharmaceutical premises, personnel and procedures must be followed by pharmaceutical manufacturers, distributors and retailers if they wish to obtain and retain their licence to operate. By means of these licences, drug regulatory authorities control the activities of pharmaceutical manufacturers, importers and distributors and companies engaged in drug promotion andadvertising.