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STRATEGIC HEALTH PLAN AND ANTICIPATED CHANGES TO MRA/MCC Dr Joey Gouws

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. Index. Migration MCC/MRA to new Entity Operational MRA/MCC: EDMS Complementary Medicines

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STRATEGIC HEALTH PLAN AND ANTICIPATED CHANGES TO MRA/MCC Dr Joey Gouws

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

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

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

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

  9. To the South African Pharmaceutical Industry THANK YOU!

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

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

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