Effective Drug Regulation - A Multicountry Study and Annex 1: Guide for Data Collection to Assess Drug Regulatory Performance: ANNEX 1: GUIDE FOR DATA COLLECTION TO ASSESS DRUG REGULATORY PERFORMANCE: 3. Regulatory functions: 3.4 Adverse drug reaction monitoring

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

3.4 Adverse drug reaction monitoring

ADR1: Is there an adverse drug reaction (ADR) monitoring system?

Yes
No

ADR1.1: If yes, collect information on when it started and how the system operates (who submits reports and whether the reporting is obligatory or voluntary):

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ADR2: How many ADRs have been recorded per year in the last five years?

	Year:	Year:	Year:	Year:	Year:
Number of ADRs reported

ADR3: What is done with the reports received? Explain how and to whom they are disseminated locally and internationally?

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ADR4: Are decisions made on the basis of ADR monitoring?

Yes
No

ADR4.1: If yes, describe how:

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ADR5: Are manufacturers/importers required to monitor and report ADRs in respect of their products?

Yes
No

ADR6: What are the main constraints, weaknesses or problems and the strengths of the ADR monitoring system?

Constraints/weaknesses/problems	Strengths

Indicators

1. Number of ADR reports assessed for causality, out of the total number of ADR reports recorded through the monitoring system (indicate year).

2. Number of products recalled based on ADR reports, out of the total number of ADR reports recorded and confirmed for causality (indicate year)

3. Number of regulatory decisions taken on the basis of ADR reports, out of the total number of ADR reports confirmed for causality (indicate year).