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: 6.3 PAYING FOR LICENSING

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

Índice de contenido

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

6.3 PAYING FOR LICENSING

Sources of finance for licensing activities are the same as those for overall drug regulation (see Chapter 5.3).

Budgets for licensing activities are provided from the overall budget of the drug regulatory authorities in each of the 10 countries. The countries differ, however, in how budgets are allocated. In Australia, the Netherlands and Venezuela, a specific sum is allocated to the division/section conducting this particular function. Others have no specific licensing budget, but expenses are paid from the overall budget. For instance, in Australia, the Conformity Assessment Branch derives its budget from the overall budget of the TGA, which is generated through industry fees. In contrast, in Malaysia, the expenses for licensing and related activities are fully funded by the Government through the Ministry of Health. Uganda and Zimbabwe levy fees for licensing of pharmaceutical premises.

Table 6.1 Legal and professional requirements for obtaining a licence to operate

	Australia	Cuba	Cyprus	Estonia	Malaysia	Netherlands	Tunisia	Uganda	Venezuela	Zimbabwe
Activity/product:
Manufacturing	Qualified person	GMP qualified person	Pharmacist/Chemist	Pharmacist or other relevant university degree	Pharmacist(s)	Qualified person	Pharmacist	Pharmacist	Pharmacist	Pharmacist
Importation	N/A	-	Not required	Same as above	Pharmacist(s)	Pharmacist	Pharmacist	Pharmacist	Pharmacist	N/A
Wholesale distribution	State Health Dept. requirements	-	Not required	Same as above	Pharmacist	Pharmacist	Pharmacist	Pharmacist	Pharmacist	Pharmacist/Pharmacy technician
Retail pharmacy	Pharmacy Board criteria, plus Health Insurance Commission	-	Pharmacist	Pharmacist	Pharmacist (for drug items only)	Pharmacist	Pharmacist	Pharmacist (annual renewal)	Pharmacist	Pharmacist
Hospital pharmacy	State health dept. & National Hospital accreditation criteria	Pharmacist	Pharmacist	Pharmacist	Pharmacist	Pharmacist	Pharmacist	Dispenser	Pharmacist	Pharmacist
Other health care facility drug outlet	-	Varies	Physicians	Pharmacist	Variable	-	-	Varies	Varies	Dispensing physicians
Import permit required:
Registered product			•	•	•		•	•
Unregistered product		•		•		•	•	•	•	•
Investigational product		•	•	•	•	•	•	•	•	•
Unregistered product for individual patient	•		•	•		•	•	•	•	•

• = Yes = No N/A = not applicable - = information or data not available