Transcript Document

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
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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:
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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 legislationinternal 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
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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 Appointed……cont.
• Current status:
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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 Appointed……cont.
• Special project (week 7 Sept):
– Audit outcome available
– MRA request info on 4 Committee
resolutions
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P&A 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,
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
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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
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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 API’s
• Medicines Act mandate control:
– Medicines
– Related substances
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Regulatory control of API’s
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: [email protected]
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