1. SAHPRA proposals Nov 2009 A GLIMPSE OF WHAT SAHPRA IS INTENDED TO BECOME KEY PROPOSALS FOR SAHPRA NOVEMBER 2009 DR NICHOLAS CRISP

2. The Challenge SAHPRA proposals Nov 2009

3. Backlog Project Sept to Nov 2009 Total 53 people to augment and assist MRA – Clerks – Technical Specialists – Evaluators – IT support – Inspectors – Managers and Deputy Registrar Audit the applications Address outstanding paperwork Industry confirmation of audit SAHPRA proposals Nov 2009

4. Backlog Project (cont) Accelerate evaluation and approval process Accelerate the EDMS implementation Secure back-ups and prepare disaster recovery Inspection of wholesalers Improve flow of documents Cautiously optimistic about the improvements But how to prevent a repeat and build a sound future..... SAHPRA proposals Nov 2009

5. Starting Point - MCC’s mandate Registration of medicines (human and animal) based on quality, safety and efficacy Control of medical devices (covered in the Act but not provided for in regulations) Approval and monitoring of clinical trials Monitoring of safety Response to signals Licensing of manufacturers, wholesalers and distributors

6. and MCC’s obligations Ensuring public safety Ensuring public protection Ensuring transparency in its processes Accountability to the public, the clients (industry and providers) and the public Responsiveness to the environment Risk assessment i.e. minimisation of harm and maximization of benefit SAHPRA proposals Nov 2009

7. Present MCC Council Committees Supported by MRA SAHPRA proposals Nov 2009

8. Cluster: Pharmaceutical and Related Product Regulation & Management Registrar MRA SAHPRA proposals Nov 2009

9. Proposed Future Independent public entity (Schedule 3 PFMA) – Board appointed by Minister and authority assigned by Minister – Committees of Board (Governance) – CEO and Executives appointed by Board – Councils (Technical Committees) Own buildings, IT, personnel and other systems Own revenue generation, retention and management – Minister of Health and Treasury approve tariffs SAHPRA proposals Nov 2009

10. Possible Structure Single Board of Management Twin Regulatory Councils (and Committees) – RCM (Regulatory Council for Medicines) 9 Standing Committees – RCMDD (Regulatory Council for Medical Devices and Diagnostics) 3 Standing Committees SAHPRA proposals Nov 2009

11. Macro Organisation SAHPRA Organorgam v3 091101.xlsx SAHPRA Organorgam v3 091101.xlsx BOARD PURPOSE: To set policy and standards for the registration and ongoing monitoring of health products within the context of a National Drug Policy and the National Health Policy Framework and to ensure good governance of the Agency and that it performs its statutory mandate to the highest levels of ethics and technical quality BOARD FUNCTIONS: 1. To provide oversight over the Authority, and in particular ensure – (a) the good governance of- and financial oversight over the Authority; (b) that the Authority performs its statutory mandate to the highest levels of ethics and technical quality; (c) alignment with National Health Policy; (d) the strategic placement of the Authority within the South African Development Community and the African continent 2. To prepare an annual strategic plan, linked to an annual budget to be reviewed and approved by the Ministry of Health (also quarterly reporting to the Minister of Health) 3. To publish quarterly performance reports for stakeholders and the general public SAHPRA proposals Nov 2009

12. Small Board, Councils, Committees SAHPRA Board (7 non-Exec, 2 Exec)(4 meetings pa) RCM (10 experts)(6 meetings pa) – Committees max 5 perm plus ad hoc (6 meetings pa) RCMDD (6 experts) (6 meetings pa) – Committees max 5 perm plus ad hoc (6 meetings pa) Councils decisions on registration – Minister Appeals Committees - Final SAHPRA proposals Nov 2009

13. Organisational improvement Reception – Electronic registration – Electronic document tracking – Project Managers – Complaints Centre Types of Assessment – All 3 types (according to policy) medicines – Move devices and in-vitro diagnostics SAHPRA proposals Nov 2009

14. Other Features More permanent Evaluators and Assessors Principle of payment upon service Increased fees Shorten TAT Fair queuing Tracking progress Communication with industry & other role-players SAHPRA proposals Nov 2009

15. Early days - Process SAHPRA - consultation and documents (after Minister authorises) Technical Task Team consultation and previous Ministerial report Needs a Project Plan – What will it look like? – What will it cost? – Can it generate its own funds? – Seed capital from where? – Personnel remuneration system, skills and numbers? – IT solutions? – Legal requirements? – Where should it be located? – Document management? SAHPRA proposals Nov 2009

16. More process Timeframes?? Consultation process – Internal – External Statutory process Budget cycle and financial compliance etc We have a long way to go ………….. SAHPRA proposals Nov 2009

17. Questions

18. SAHPRA proposals Nov 2009