1. Select committee on Social Services 06 November 2018
South African health products REGULATORY authority (sahpra) PROGRESS report 2018
Select committee on Social Services
06 November 2018

2. OUTLINE Background Macro organizational structure of SAHPRA
SAHPRA vision and mission
Legislative mandates
Strategic outcome oriented goals
Strategic objectives
Key achievements per program
Key challenges and contingency measures

3. BACKGROUND
SAHPRA established in terms of the Medicines and Related Substances Act (Act 101 of 1965), as amended, to replace the MCC.
SAHPRA is Schedule 3A public entity: regulation of all medicines including complementary medicines, medical devices and IVDs, radiation emitting devices and radioactive nucleides.
Minister of Health appointed Board 2 October 2017.
Acting CEO appointed by the Board after consultation with the Minister of Health.
Staff transfer agreement signed October 2018 (section 197) following lengthy Bargaining Chamber processes.
Board Committees: Finance, Risk, Audit and Governance, HR and Remuneration, IT, Technical Oversight and Regulatory Strategy, Communication.
SAHPRA operational on February 1st 2018 with first Board.
1st annual report due financial year 2018/19

4. Macro Organizational Structure of SAHPRA

5. VISION AND MISSION Our Vision: Our Mission:
To strive towards excellence in health product regulation with the aim of promoting and protecting human and animal health in South Africa, being recognised and respected both nationally and globally as a leading and exemplary health product regulator
Our Mission:
To safeguard the health and wellbeing of all who live in South Africa and to support human and animal health through scientific and ethical regulation of medicines, medical devices, radiation emitting devices and radioactive nucleides

6. LEGISLATIVE MANDATES
The Constitution of the Republic of South Africa, 1996 (Act 108 of 1996)
The National Health Act, 2003 (Act 61 of 2003)
The Medicines and Related Substances Act , (Act 101 of 1965) as amended
Other Health-Related Acts
Other Legislation

7. STRATEGIC OUTCOME ORIENTED GOALS
Demonstrate responsiveness and accountability as an effective and efficient high performance organisation
Goal Statement :
SAHPRA is an effective and efficient high performing organisation that is responsive and publicly accountable.
Indicator :
Audit Outcome
Goal 2:
Timeous regulatory decisions taken on applications to ensure compliance to defined standards of quality, safety, efficacy and/or performance
Goal Statement:
Timeous regulatory decisions based on defined standards for Quality, Safety, Efficacy and Performance.
Indicator:
Regulatory decision taken within a specified timeline
This are the goals and are currently under review following the comments received from the Portfolio committee
Goal 3:
Re-evaluate and monitor medicines and medical devices periodically.
Goal Statement:
Establish a framework to ensure that registered products are periodically re-evaluated in accordance with defined standards of Quality, Safety, Efficacy and Performance
Indicator:
Framework finalised and approved within a specified timeline

8. STRATEGIC OUTCOME ORIENTED GOALS
Investigate, monitor, analyse, solicit and act upon existing and new adverse events, interactions, information with regard to post-marketing surveillance and vigilance.
Goal Statement:
Ensure that evidence of existing and new adverse events, interactions, signals emerging from post-marketing surveillance and vigilance is being solicited, investigated, monitored, analysed and acted upon; and establish supportive national and global partnerships.
Indicator:
Published quarterly reports of new adverse events and signals that have been assessed, actioned and concluded.
Goal 5:
Ensure regulatory compliance through a process of active Inspections and investigations.
Goal :
Inspect and Investigate Establishments and permit holders in accordance with defined guidelines & standards
Indicator:
% of Establishments inspected within specified timelines
% of permits issued within specified timelines.
Goal 6:
Evaluate clinical trial protocols in accordance with defined standards
Goal Statement:
Clinical trial protocols are evaluated in accordance with the defined standards to ensure participant safety and data integrity.
Indicator:
% of clinical trial protocols evaluated within a specified timeline

9. STRATEGIC OUTCOME ORIENTED GOALS
Evaluate applications for sale of unregistered health products in accordance with defined standards.
Goal
Ensure that unregistered health product applications are evaluated in accordance with defined standards to ensure access only to safe, efficacious and quality unregistered health products.
Indicator:
% of applications for the sale of an unregistered health product evaluated within a specified timeline.
Goal 8
Establish and strengthen collaborative initiatives with any other regulatory authority or institutions in order to achieve the objects of the Medicines Act.
Goal
Liaise with any other regulatory authority or institution with a view to exchange information with and receive information from any such authority or institution in respect of—(i) matters of common interest; or (ii) a specific investigation; and enter into agreements of collaboration with any regulatory authority or other relevant organisations.
Indicator:
Establish at least 9 collaborative relationships to support the functions of SAHPRA
Goal 9
SAHPRA is capacitated by adequate, competent and motivated human capital
Goal
A functional SAHPRA with a budget and personnel to implement the Authority’s mandate effectively is phased in and fully operational by 2023.
Indicator
% of funded positions filled

10. SAHPRA STRATEGIC OBJECTIVES
Strategic objectives adopted by the Board and SAHPRA are as follows.

11. KEY ACHIEVEMENTS

12. PROGRAMME ONE: ADMINISTRATION

13. PROGRAMME PURPOSE
To provide the leadership and administrative support necessary for SAHPRA to deliver on its mandate and comply with all relevant legislative requirements.
Programme 1 has four sub-programmes:
Sub-Programme 1: Financial and Supply Chain Management
Sub-Programme 2: Governance and Compliance
Sub-Programme 3: Information Technology and Communication
Sub-Programme 4: Human Resource Management

14. KEY ACHIEVEMENTS
Sub-Programme 1: Financial and Supply Chain Management
Finance, Supply chain and donations policies finalised
The Board manages its finances under the direction of the Public Finance Management Act (PFMA) through the Office of the CFO.
SAHPRA revenue earned for period 1 February to 31 March will be accounted for in the SAHPRA AFS for year ending 31 March 2019.
An exemption was requested in terms of Section 55 A of the PFMA from National Treasury. A letter has been tabled before the speaker in terms of Section 65(2) (a) to provide a written explanation setting out reasons why SAHPRA has not tabled the annual report and financial statement for the period 2017/18.

15. KEY OUTPUTS
Expenditure incurred of SAHPRA for the will be accounted for and reported in annual financial statements (AFS) of National Department of Health.
Revenue collected by SAHPRA for services rendered to the pharmaceutical and medical industry for financial year amounted to R 74,9 million.
Revenue generated for 10 months (1 April 2017 to 31 January 2018) while the Authority was known as the MCC amounted to R63,5 million.
Revenue will be accounted for and reported in the NDOH AFS and transferred to the National Revenue Fund via the NDOH. SAHPRA retained R11,4 million of revenue earned for period 1 February to 31 March 2018.
This will be accounted for in SAHPRA AFS for year ended 31 March 2019.

16. Summary of economic classification
Actual Expenditure
7/11/2019
The month ending 31 August 2018 results are as follows.
Summary of economic classification
Total Budget 2018/19
Actual at 31 August 2018
Available budget
% Budget Available
Revenue
Transfer payment
125,189,000
62,594,500
50%
Fees received
90,681,000
30,859,551
59,821,449
34%
Interest received -
1,047,521
,047,521
Total
215,870,000
94,501,572
121,368,428
TOTAL CURRENT PAYMENTS
Compensation of employees
149,145,380
42,223,068
106,922,313
72%
Goods and services
66,724,620
12,259,419
54,465,201
82%
Capital payments
188,521
54,671,008
161,387,513

17. SAHPRA Finances 2018/19 Progress on Finance units:
Sage Pastel Partner additional licences for finance unit
Sage People HR & Payroll – System procured. To be used when staff from NDOH is transferred to SAHPRA
Existing contracts with the NDOH transferred to SAHPRA
Assets transferred to SAHPRA on 2nd August 2018
Bank account transferred from NDOH profile to SAHPRA profile end of Oct (on-boarded at ABSA)
Critical staff member of Finance - CFO – interviews concluded

18. SAHPRA Finances 2018/19 Still required – Finance unit:
Major expenditures to be concluded in this financial year: (Included in /19 Budget)
Building / Accommodation tender for new premises of SAHPRA
IT infrastructure upgrade
Additional SQL licences for payroll
Additional IT equipment to be purchased for critical staff
Service provider for HR & payroll support for critical staff (10 people) whilst SAHPRA does not have capacity
Service provider (GTAC) for corporate services
Additional ringfenced funding for ‘Backlog Project’ being sought

19. SAHPRA Finances 2018/19
Challenges faced with the industrial action at Civitas Building
SCM processes delayed as submission were not timeously attended to since protest action started April 2018
This delayed order numbers for goods and services required and payments to suppliers
Mitigations to avoid further delays:
Corporate services assistance to capacitate SAHPRA’s procurement units

20. KEY ACHIEVEMENTS Sub-Programme 2: Governance and Compliance
Board manages its governance set out in the compliance framework and Policies of Risk, Audit and Governance.
This programme will be supported by the following offices: Board Secretary and Legal Services, strategic Planning and Monitoring, and Quality Management Systems.
Policies and Risk Registers developed

21. KEY ACHIEVEMENTS
Sub-Programme 3: Information Technology and Communication
ICT Policy and Strategy developed and approved by Board. The strategy focuses on data management and digitization of functions of SAHPRA.
The domain “sahpra.org.za” was secured.
The SAHPRA Logo was approved by the Board
Website being updated
New Board Communications Committee established to strengthen public communication and support pharmacovigilance

22. KEY ACHIEVEMENTS Sub Programme 4 - Human Resources Transfer of staff
Recruitment and Selection Policy and HR policies finalised
In process of filling critical senior posts: CEO, CFO, Director: Human Resources, Director: Information Technology and Communication, Board Secretary, Chief Regulatory Officer.
Transfer of staff
Staff Transfer Agreement signed in October 2018: Section 197 and staff formally notified of transfer October 2018

23. Procurement of SAHPRA accommodation in process
Project Working Group: x4 meetings held: made recommendations to the CEO
Core team
SAHPRA MANAGEMENT TEAM
Needs analysis: Business and Space
Parking
Request For Proposal Bid specs
Financial analysis: Treasury & own budget
Recommendations to CEO
Union representatives
National Treasury, GTAC, NDoH
Budget input
SCM support
Engineer
Bid Committee setup
Lease drafting and negotiation support
Other Project Partners
Health and safety
Legal
Engineer
Project management
Tender
NDoH/National Treasury
NDoH/National Treasury
Acting CEO's Office

24. Process timelines very tight
EVENTS TO DATE
Milestones
1.0 Engagement with GTAC (PPP)
2.0 Engagement with NDOH SCM
3.0 Re-engagement with GTAC
4.0 Bid Specification Committee
PPP technical assistance possibility
Letter written to the GTAC (05/09/2018)
Positive response received
2.1 Request for SCM assistance Skeleton staff (protest action)
3.1 Request for SCM assistance with procurement of the SAHPRA accommodation
and advertisement
4.1 TORs being drafted
4.2 Specs drawn up by internal Working Group to be confirmed
Process timelines very tight
5.0 Bid Evaluation Committee
6.0 Bid Adjudication Committee
7.0 Lease agreement
8.0 Measurement
8.1 Measure Project Performance
NB Closure of Civitas means that urgent alternative accommodation must be immediately sought: Emergency discussions with labour and staff about relocation in progress

25. OTHER ACHIEVEMENTS
Collaborative relationships with other medicines regulatory authorities and regulatory bodies strengthened:
Zazibona
Pharmaceutical Inspections Cooperation scheme (PICS)
WHO
African Vaccines Regulatory Forum (AVAREF),
International Council for Harmonisation (ICH) and Veterinary International Cooperation on Harmonisation (VICH)
Regulators: Swissmedic, US FDA (Food and Drug Administration), European Medicines Agency (EMA).
Several stakeholder meetings and workshops held –
Pharma, Medical device, clinical trials and Complementary medicines industry and associations, round table discussions with CEO’s of industry
Laboratories - for the release of vaccines

26. AUTHORISATION MANAGEMENT
PROGRAMME TWO:
AUTHORISATION MANAGEMENT

27. PROGRAMME PURPOSE
To provide administration support necessary for SAHPRA to deliver on its mandate and comply with the relevant legislative requirements.
To co-ordinate the process of registration and/or licensing or amendment of applications in respect of medicines within a legislative framework that defines the requirements necessary for application to the Authority, to receive, record and distribute all documents submitted to SAHPRA, to manage and maintain SAHPRA’s main Registry.

28. A critical first task for SAHPRA is the clearance of the inherited medical products backlog, defined as:
All applications1 submitted which are yet to receive final approval (including certification), as of 31 January 20182
1. Includes duplicates, clones, multiple doses and multiple dosage forms 2. SAHPRA was formed on 1 February 2018

29. Top facts about the backlog
SAHPRA’s backlog comprises ~16,000 applications: 8,300 new registration and 7,200 variations
SAHPRA’s backlog dates back to 1992
50% of the new registrations backlog is ≥5 years old (submitted 2013 or earlier)
16 applicants account for 50% of the new registrations backlog
Generics comprise >90% of the new registrations backlog
15 molecules comprise 16% of the new registrations backlog, each averaging 20 applicants — which provides a batch processing opportunity
Clinical applications represent 40% of the variations backlog
There are 3,400 variations amendments awaiting certification: a relative “quick-win” 1 2 3 4 5 6 7 8

30. To clear the backlog within 2 years, there are three pillars to SAHPRA's backlog clearance strategy
Reduce the number of applications that require evaluation
Segment and prioritise remaining applications
Design and implement new models for evaluation
"Opt-in" for pre-2014 new registration applications
Consolidate and update all applications
Reject poor quality applications
Public health need will determine the order of evaluation
Public health risk will determine the evaluation pathway
New evaluation policies – relying on the decisions of stringent regulatory authorities
Radically improved operating model
Source: BCG analysis

31. SAHPRA's new operating model
Evaluation policies
Streamlined processes
Upfront admin. and technical screening
Batch processing by API
Top-down (summary) approach to full reviews
Team-leader peer-review model
Staffed for success
New, dedicated backlog evaluation team
New positions: Application Managers, External Evaluator Coordin., Comms Manager
Improved utilisation
Digitally empowered
All re-submitted, updated applications should be electronic or eCTD
New, simple, standardised document tracking system
Published list of APIs and # of applications in backlog
SAHPRA's new operating model
Transparency and accountability
Effective program management

32. Despite challenges, SAHPRA is making progress towards establishing an efficient, effective regulator
Finding fit-for-purpose building
Progressing the appointment of a new Executive Team
Nearing finalisation of Section 197 transfer of staff
Dramatic re-engineering / automation of Section 21 processes

33. KEY ACHIEVEMENTS Analysed and verified the extent of the backlog
Backlog elimination strategy developed and approved by the Board
Currently working on implementation plan
The goal is to clear backlog within 2 years starting 2019
Dedicated budget of between R 250 – 300 million required to achieve this and funds being sought from government with support of DG and Minister and from donor funding

34. INSPECTORATE AND REGULATORY COMPLIANCE
PROGRAMME 3:
INSPECTORATE AND REGULATORY COMPLIANCE

35. PROGRAMME PURPOSE
To ensure public access to safe or quality health products (include disclaimer) through inspections and regulatory compliance. The focus of this programme includes assessment of site compliance, with good regulatory and vigilance practices, including:
Good Manufacturing Practice (GMP);
Good Clinical Practice (GCP);
Good Warehouse Practice (GWP);
Good Distribution Practice (GDP);
Good Laboratory Practice (GLP);
Good Vigilance Practice(GVP)

36. KEY ACHIEVEMENTS Inspections Active Pharmaceutical Ingredient (API)
Medicine and medical device manufacturers
Wholesalers,
Pharmacovigilance
Clinical trial sites, located both locally and internationally;
Inspection and monitoring of compliance with applicable legislation as mandated (Medicines and Related Substances Act, 1965, Hazardous Substances Act, 1973).
Review of work completed in this programme is split between licensing and regulatory compliance.

37. MEDICINES EVALUATION AND REGISTRATION
PROGRAMME 4:
MEDICINES EVALUATION AND REGISTRATION

38. PROGRAMME PURPOSE
To evaluate the safety, quality and therapeutic efficacy of medicines and register them for use as per delegated authority in terms of relevant legislation as listed in the legal mandate.
Functions
Management of the evaluation of applications to ensure safety, quality and efficacy of products.
Management of the registration and control of medicines.
Management of regulations pertaining to the sales of medicines.
Establishment of surveillance mechanisms to detect, assess and prevent adverse reactions to health products.
Management of the authorisation of sale of unregistered medicine for specified purposes in terms of relevant legislation. 44

39. KEY ACHIEVEMENTS
Using same approach as developed for the Backlog Project, new more efficient methods introduced for routine evaluations going forward including reliance mechanisms that take account of other international regulatory approvals
New approaches to identify and approve products of public health importance for expedited review
Evaluation of Medicines required for HIV, TB and cancer, New Chemical Entities (NCE) and biological medicines prioritized through expedited review
Appointment of expert evaluators and advisory committees for Backlog project and for new application processes
Online S21 application system (approval of unlicensed drugs required for emergencies and specific disease management) was implemented

40. MEDICAL DEVICES, DIAGNOSTICS AND RADIATION CONTROL
PROGRAMME 5:
MEDICAL DEVICES, DIAGNOSTICS AND RADIATION CONTROL

41. PROGRAMME PURPOSE
To develop and maintain regulations and guidelines pertaining to the regulatory oversight of medical devices, ionizing and non-ionizing radiation emitting devices; and radioactive nucleides. Core functions for this programme include:
Licensing of medical device establishments;
Registration of medical devices and radiation emitting devices and radioactive nucleides;
Designation and supervision of conformity assessment bodies;
Conducting inspections of medical device establishments;
Post-marketing surveillance and vigilance; and
Approval of clinical trials.

42. KEY ACHIEVEMENTS
The focus of the Medical Device unit was to phase in the work of the unit as per the road map for implementing the regulation of medical device. Several workshops were held with the medical device industry
Licensing of medical device establishments is underway while concurrently developing a framework for the registration of medical devices.
The Radiation Control Unit primarily covers the registration and inspection of products and sites of Group III and IV radioactive nucleides and radiation emitting devices.
The work is split among 3 offices in Cape Town, Durban and Pretoria, and was under capacitared for many years resulting in permit backlogs.
Key posts that are not on the post establishment have been identified as critical and a strategy to fill these posts is being implemented and backlog is being addressed

43. Key Challenges and Contingency Measures
Inherited backlogs for medicines and radiation control
Major delays to effect the Section 197 transfer of staff form DoH to SAHPRA.
Full autonomy from the NDOH not yet achieved
Urgent requirement for new building because of Civitas challenge
Protest action has negatively impacted on SAHPRA
Increased backlogs
Delays in appointment of key senior staff
Delays in registration of public health priority medicines- TB, HIV, Oncology, NCDs
Delay in issuing of permits: Section 21 required for patients suffering from life-threatening conditions to have access to unregistered medicines; radiation control; narcotics
Backlog project developed in consultation with industry: 2 year programme to be commenced in 2019 if funds secured from government and donor sources
SAHPRA policies developed and Corporate services assistance to capacitate SAHPRA’s procurement units in process. Section 197 staff transfer recently approved.
New building being identified as emergency intervention
Temporary relocation of critical services including Section 21: Successful automation of Section21 permits achieved
Backlog of issuing of narcotic permits addressed
Radiation Control backlog addressed – Acting Director and Acting DD appointed, experts appointed to assist with complex applications.
Pharmacovigilance & communication being strengthened

44. THANK YOU FOR YOUR ATTENTION