SAHPRA proposals Nov 2009
A GLIMPSE OF WHAT SAHPRA IS A GLIMPSE OF WHAT SAHPRA IS INTENDED TO BECOMEINTENDED TO BECOME
KEY PROPOSALS FOR SAHPRA
NOVEMBER 2009
DR NICHOLAS CRISP
The Challenge
SAHPRA proposals Nov 2009
Backlog Project
Sept to Nov 2009 Total 53 people to augment and assist MRA
– 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)
Accelerate evaluation and approval process Accelerate the EDMS implementation Secure back-ups and prepare disaster recovery Inspection of wholesalers Improve flow of documents
Cautiously optimistic about the improvements
But how to prevent a repeat and build a sound future .....
SAHPRA proposals Nov 2009
SAHPRA proposals Nov 2009
Starting Point - MCC’s mandate
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
and MCC’s obligations
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
Council Committees
Supported by MRA
SAHPRA proposals Nov 2009
Cluster: Pharmaceutical and Related Product Regulation & Management
Registrar MRA
SAHPRA proposals Nov 2009
Proposed Future
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
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
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
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
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
SAHPRA - consultation and documents (after Minister authorises) Technical Task Team consultation and previous Ministerial report Needs a Project Plan
– 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
Timeframes?? Consultation process
– Internal– External
Statutory process Budget cycle and financial compliance etc
We have a long way to go …………..
SAHPRA proposals Nov 2009
SAHPRA proposals Nov 2009
Questions
SAHPRA proposals Nov 2009