1. 1 STRATEGIC HEALTH PLAN AND ANTICIPATED CHANGES TO MRA/MCC Dr Joey Gouws Director: Inspectorate and Law Enforcement Medicines Regulatory Authority (MRA) South Africa 04 September 2009

2. 2 Index Migration MCC/MRA to new Entity Operational MRA/MCC: EDMS Complementary Medicines Marketing Code for Medicines Regulations on API Manufacturing and Wholesaling

3. 3 MCC Mandate: Current Registration of medicines Control of Medical Devices Authorisation and monitoring of Clinical trials Monitoring of safety Responses to signals Licensing of Manufacturers and Wholesalers

4. 4 MCC/MRA Structure: Current MCC and Expert Committees: External MRA Cluster: Internal –Cluster Manager / Registrar –4 Directorates

5. 5 MCC/MRA Structure: Future Independent Public Entity ? Parastatal Public Entity ?

6. 6 Reason for Restructuring Reports from various Task Teams: –1997, 1998, 2008, 2009 Outcomes: –Under resourced –Under financed –Limited space –Infrastructure –Timelines to registration!!!

7. 7 New Structure: Requirements Efficient MCC-priority for MoH Envisage: amendment to the current legislation- HR, Finance, Processes Registration timelines in legislation- internal evaluators v external evaluators Contracts with performance indicators

8. 8 Interim measures: Backlog Task Team Appointed Contracted 55 staff to work on backlog Contracted 7 SAPC Inspectors to assist with GWP inspections

9. 9 To the South African Pharmaceutical Industry

10. 10 Interim measures: Backlog Task Team Appointed….cont. 3 Tier process: –1 st phase: Screening –2 nd phase: Audit –3 rd phase: Allocation to evaluators

11. 11 Interim measures: Backlog Task Team Appointed……cont. Current status: –Screening up to date –Clinical trials up to date –Data base on applications –Space constraints: archive and move 7000 Metrofile boxes (30 October) –Licence applications / renewals –Weekly progress meetings

12. 12 Interim measures: Backlog Task Team Appointed……cont. Special project (week 7 Sept): –Audit outcome available –MRA request info on 4 Committee resolutions P&A Committee Scheduling Names Clinical Committee

13. 13 Operational MRA/MCC: EDMS MCC/MRA Server EDMS –Specific process flow for each type of application (PI update, P&A Amendment) –Automatic eMail notification –No Screening –Training of MRA staff (6 week process): October 2009 Implementation of eCTD: pilot run October 2009 New MCC website: www.mra.gov.za

14. 14 Complementary medicines MCC reviewed applications submitted Serious concerns on the safety of the public Urgent need for Regulatory control Media release (2-3 weeks)

15. 15 Marketing Code for Medicines Proposed Marketing Code: Industry Final version: 24 August 2009 Authority to enforce Code: Regulations Regulatory compliance: add as “Condition of Registration”

16. 16 Regulations for control of API’s Medicines Act mandate control: –Medicines –Related substances Regulatory control of API’s API: Manufacture and Wholesale licensing API GMP-part of SA Guide (2007) Constraint: Resources

17. 17 Enjoy your SAPRAA morning! Dr Joey Gouws Director: Inspectorate and Law Enforcement Medicines Regulatory Authority (MRA) South Africa email: gouwsj@health.gov.za