STRATEGIC HEALTH PLAN AND ANTICIPATED CHANGES TO MRA/MCC

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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
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Index

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

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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

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MCC/MRA Structure Current

• MCC and Expert Committees External
• MRA Cluster Internal
• Cluster Manager / Registrar
• 4 Directorates

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MCC/MRA Structure Future

• Independent Public Entity ?
• Parastatal Public Entity ?

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Reason for Restructuring

• Reports from various Task Teams
• 1997, 1998, 2008, 2009
• Outcomes
• Under resourced
• Under financed
• Limited space
• Infrastructure
• Timelines to registration!!!

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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

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Interim measures Backlog Task Team Appointed

• Contracted 55 staff to work on backlog
• Contracted 7 SAPC Inspectors to assist with GWP
  inspections

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To the South African Pharmaceutical Industry
THANK YOU!

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Interim measures Backlog Task Team
Appointed.cont.

• 3 Tier process
• 1st phase Screening
• 2nd phase Audit
• 3rd phase Allocation to evaluators

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Interim measures Backlog Task Team
Appointedcont.

• 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

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Interim measures Backlog Task Team
Appointedcont.

• Special project (week 7 Sept)
• Audit outcome available
• MRA request info on 4 Committee resolutions
• PA Committee
• Scheduling
• Names
• Clinical Committee

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Operational MRA/MCC EDMS

• MCC/MRA Server
• EDMS
• Specific process flow for each type of
  application (PI update, PA 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

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Complementary medicines

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

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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

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Regulations for control of APIs

• Medicines Act mandate control
• Medicines
• Related substances
• Regulatory control of APIs
• API Manufacture and Wholesale licensing
• API GMP-part of SA Guide (2007)
• Constraint Resources

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