Transcript CONSULTING IN THE LOCAL AND INTERNATIONAL HEALTH …

A GLIMPSE OF WHAT SAHPRA IS
INTENDED TO BECOME
KEY PROPOSALS FOR SAHPRA
NOVEMBER 2009
DR NICHOLAS CRISP
SAHPRA proposals Nov 2009
The Challenge
SAHPRA proposals Nov 2009
Backlog Project
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Sept to Nov 2009
Total 53 people to augment and assist MRA
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Clerks
Technical Specialists
Evaluators
IT support
Inspectors
Managers and Deputy Registrar
Audit the applications
Address outstanding paperwork
Industry confirmation of audit
SAHPRA proposals Nov 2009
Backlog Project (cont)
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Accelerate evaluation and approval process
Accelerate the EDMS implementation
Secure back-ups and prepare disaster recovery
Inspection of wholesalers
Improve flow of documents
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Cautiously optimistic about the improvements
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But how to prevent a repeat and build a sound future .....
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SAHPRA proposals Nov 2009
Starting Point - MCC’s mandate
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Registration of medicines (human and animal) based on
quality, safety and efficacy
Control of medical devices (covered in the Act but not provided
for in regulations)
Approval and monitoring of clinical trials
Monitoring of safety
Response to signals
Licensing of manufacturers, wholesalers and distributors
SAHPRA proposals Nov 2009
and MCC’s obligations
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Ensuring public safety
Ensuring public protection
Ensuring transparency in its processes
Accountability to the public, the clients (industry and providers)
and the public
Responsiveness to the environment
Risk assessment i.e. minimisation of harm and maximization of
benefit
SAHPRA proposals Nov 2009
Present MCC
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Council
Committees
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Supported by MRA
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SAHPRA proposals Nov 2009
Cluster: Pharmaceutical and Related
Product Regulation & Management
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Registrar
MRA
SAHPRA proposals Nov 2009
Proposed Future
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Independent public entity (Schedule 3 PFMA)
– Board appointed by Minister and authority assigned by
Minister
– Committees of Board (Governance)
– CEO and Executives appointed by Board
– Councils (Technical Committees)
Own buildings, IT, personnel and other systems
Own revenue generation, retention and management
– Minister of Health and Treasury approve tariffs
SAHPRA proposals Nov 2009
Possible Structure
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Single Board of Management
Twin Regulatory Councils (and Committees)
– RCM (Regulatory Council for Medicines)
 9 Standing Committees
– RCMDD (Regulatory Council for Medical Devices and
Diagnostics)
 3 Standing Committees
SAHPRA proposals Nov 2009
Macro Organisation
SAHPRA Organorgam v3 091101.xlsx
BOARD PURPOSE: To set policy and standards for the registration and ongoing monitoring of
health products within the context of a National Drug Policy and the National Health Policy
Framework and to ensure good governance of the Agency and that it performs its statutory
mandate to the highest levels of ethics and technical quality
BOARD FUNCTIONS:
1. To provide oversight over the Authority, and in particular ensure –
(a) the good governance of- and financial oversight over the Authority;
(b) that the Authority performs its statutory mandate to the highest levels of ethics and
technical quality;
(c) alignment with National Health Policy;
(d) the strategic placement of the Authority within the South African Development
Community and the African continent
2. To prepare an annual strategic plan, linked to an annual budget to be reviewed and approved
by the Ministry of Health (also quarterly reporting to the Minister of Health)
3. To publish quarterly performance reports for stakeholders and the general public
SAHPRA proposals Nov 2009
Small Board, Councils,
Committees
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SAHPRA Board (7 non-Exec, 2 Exec)(4 meetings pa)
RCM (10 experts)(6 meetings pa)
– Committees max 5 perm plus ad hoc (6 meetings pa)
RCMDD (6 experts) (6 meetings pa)
– Committees max 5 perm plus ad hoc (6 meetings pa)
Councils decisions on registration
– Minister Appeals Committees - Final
SAHPRA proposals Nov 2009
Organisational improvement
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Reception
– Electronic registration
– Electronic document tracking
– Project Managers
– Complaints Centre
Types of Assessment
– All 3 types (according to policy) medicines
– Move devices and in-vitro diagnostics
SAHPRA proposals Nov 2009
Other Features
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More permanent Evaluators and Assessors
Principle of payment upon service
Increased fees
Shorten TAT
Fair queuing
Tracking progress
Communication with industry & other role-players
SAHPRA proposals Nov 2009
Early days - Process
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SAHPRA - consultation and documents (after Minister authorises)
Technical Task Team consultation and previous Ministerial report
Needs a Project Plan
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What will it look like?
What will it cost?
Can it generate its own funds?
Seed capital from where?
Personnel remuneration system, skills and numbers?
IT solutions?
Legal requirements?
Where should it be located?
Document management?
SAHPRA proposals Nov 2009
More process
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Timeframes??
Consultation process
– Internal
– External
Statutory process
Budget cycle and financial compliance
etc
We have a long way to go …………..
SAHPRA proposals Nov 2009
Questions
SAHPRA proposals Nov 2009
SAHPRA proposals Nov 2009