Note: Changes made on this electronic version not on printed copy:

• All hypertext links to outside pages eg to Medicines Control Act, National Drug Policy
• Under section 6.10 reference to section 5.3 changed to section 6.3
• Under section 8.2 reference to section 5.2 changed to section 6.2
• CV of Wilbert Bannenberg, para 3, "assisyed" changed to "assisted"
• Supplementary note #10, changed "used" to "uses"
• Supplementary note #24, reference to section 5.3 changed to 6.3
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Contents

Acknowledgements

EXECUTIVE SUMMARY

1. Introduction
2. Strengths and deficiencies in the present system for registration of medicines

2.1 Strengths
2.2 Deficiencies

3. Constraints and conditions for change
4. Medicines policies
5. Principal elements in a new regulatory system

5.1 Need for national regulation
5.2 Principles
5.3 Status
5.4. Roles
5.5. Structure
5.6 Standards
5.7 Priorities
5.8 Confidentiality versus freedom of information
5.9 Avoidance of conflicts of interest
5.10 International activities

6. Associated systems

6.1 The Inspectorate of Medicines
6.2 Drug safety monitoring
6.3 Drug information and rational prescribing
6.4 Drug utilisation studies
6.5 Licensing of clinical trials
6.6 Access to unregistered products
6.7 Dental medicines and materials
6.8 Veterinary medicines
6.9 Cosmetics
6.10 Medicines costs: strategies and cost containment
6.11 Medical devices and materials

7. Legal provisions
8. Financial aspects

8.1 Fees
8.2. External contracts
8.3 Reimbursement of members of committees
8.4 Financial analysis

9. Transitional measures

9.1 Appointment of an interim council
9.2 Appointment of transitional management
9.3 Clearing the backlog
9.4 Establishment of new structure
9.5 Technical assistance requirements.

10. Time/flow chart

Tables and Figures:

TABLE 1
TABLE 2
Figure 1
Figure 2
Figure 3
Figure 4

Appendices:

1. Review Team
2. Terms of reference
3. Income and expenditure summary
4. Documents consulted
5. Persons consulted
6. Submissions received

Supplementary notes

© 1998 Department of Health, South Africa
Reproduction and commercial distribution of this document is prohibited without written agreement of the Department of Health.