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STRATEGIC HEALTH PLAN AND ANTICIPATED CHANGES TO MRA/MCC Dr Joey Gouws Director: Inspectorate and Law Enforcement Medi PowerPoint Presentation
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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

Director: Inspectorate and Law Enforcement

Medicines Regulatory Authority (MRA)

South Africa

04 September 2009

index
Index
  • Migration MCC/MRA to new Entity
  • Operational MRA/MCC: EDMS
  • Complementary Medicines
  • Marketing Code for Medicines
  • Regulations on API Manufacturing and Wholesaling
mcc mandate current
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
mcc mra structure current
MCC/MRA Structure: Current
  • MCC and Expert Committees: External
  • MRA Cluster: Internal
    • Cluster Manager / Registrar
    • 4 Directorates
mcc mra structure future
MCC/MRA Structure: Future
  • Independent Public Entity ?
  • Parastatal Public Entity ?
reason for restructuring
Reason for Restructuring
  • Reports from various Task Teams:
    • 1997, 1998, 2008, 2009
  • Outcomes:
    • Under resourced
    • Under financed
    • Limited space
    • Infrastructure
    • Timelines to registration!!!
new structure requirements
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
interim measures backlog task team appointed
Interim measures: Backlog Task Team Appointed
  • Contracted 55 staff to work on backlog
  • Contracted 7 SAPC Inspectors to assist with GWP inspections
interim measures backlog task team appointed cont
Interim measures: Backlog Task Team Appointed….cont.
  • 3 Tier process:
    • 1st phase: Screening
    • 2nd phase: Audit
    • 3rd phase: Allocation to evaluators
interim measures backlog task team appointed cont11
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
interim measures backlog task team appointed cont12
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
operational mra mcc edms
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
complementary medicines
Complementary medicines
  • MCC reviewed applications submitted
  • Serious concerns on the safety of the public
  • Urgent need for Regulatory control
  • Media release (2-3 weeks)
marketing code for medicines
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”
regulations for control of api s
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
slide17

Enjoy your SAPRAA morning!

Dr Joey Gouws

Director: Inspectorate and Law Enforcement

Medicines Regulatory Authority (MRA)

South Africa

email: gouwsj@health.gov.za