Enhancing Regulatory Oversight in Medicines and Healthcare

 
THE MCC
 
Today and the future
 
                                                                                        Mandisa Hela
 
Let us recap on OBLIGATIONS
 
Public safety & protection through ensuring efficacy,
safety & quality of medicines throughout their
lifecycle
Risk assessment – minimization of harm and
maximization of benefit
Timely access to medicines & timely action on safety
& quality
Transparency & accountability
Responsiveness
Capacity to regulate
 
2
 
How is the MCC doing ?
 
Quality of  reviews – well
Members of PICS
Supply chain integrity - reasonable
Timeliness – poor
Transparency – limited
Responsiveness – needs improvement
Capacity – suboptimal
 
Where did we go wrong
 ?
 
Current structure conceived more than 40
years ago
Over - reliance on external experts
Internal technical expertise limited –
Government department
Government implemented pro-access policies
without doing an impact assessment,
analysing and adapting affected units
 
Gaps
 
Do not regulate complementary and alternative
medicines
Do not regulate African traditional medicines
Do not regulate medical devices and in vitro
diagnostics
Do not regulate cosmetics
Do not adequately regulate blood products and
antivenins
Do not adequately regulate adequately starting
materials  - amending legislation
 
HOW ARE WE FILLING THE GAPS
 
Establishment of SAHPRA  as public entity
Regulation of orthodox medicines
Regulation of complementary and alternative
medicines
Regulation of African traditional medicines
Regulation of medical devices and in vitro
diagnostics
Regulation of foodstuffs and cosmetics
 
How are we filling the gaps ? 
cont
.
 
Increasing internal capacity
Numbers
Skills base
Attitude
Improve peer review system – frequency of meetings
Specialised areas -retainer system
Reorganise the appeal process
Cooperation with recognised regulatory
authorities on cutting edge issues
 
 
Current challenges
 
New technologies which respond to
conditions exclusively or overwhelmingly
prevalent in our country e.g. MDR and XDR TB
New type of applicant e.g.
Product Development Partnerships
Balancing early access to new drugs with the
need for comprehensive data
Managing newer technologies e.g. biosimilars
Managing borderline devices or medicines
Maintaining access for older molecules
 
 
8
 
Emerging challenges
 
Regulation of advanced therapy
medicinal products
Gene therapy medicinal products, Tissue engineered
products , biologicals containing GMOs
Combined products with devices used as excipients
or carriers
Emerging / evolving areas  e.g. Advanced therapies
with accompanying diagnostics
 
9
 
What is happening globally?
 
Work sharing among regulators
Co-evaluation
Abridged methods that avoid duplication of effort
In relation to supply chain integrity:
electronic symbology initiatives to ensure
interoperability of tracking systems across the
supply chain
Linkage between regulators and Health
technology assessment
Involvement of the public in regulation
 
10
 
What is the way forward ?
 
Co- operation with other regulators is imperative
from an efficiency, capacity and responsiveness
point of view
How?
What is in the tool box?
What frameworks do we need?
Are currently available tools sharp enough? Are
they robust enough?
What can we adapt to attain a perfect fit to our
needs?
 
 
 
11
 
Food choices
 
Food choices
 
Food choices
 
Stepping Stones
 
Shared vision
Consistency, transparency and responsiveness
Communication, education & training
Common standards
Enabling Legal instruments
Coordination & cooperation
Trust & mutual respect
A pinch of optimism, an ounce of patience and a
healthy dose of perseverance
 
 
15
 
A glimpse into the future
 
Is all this pointing to a global regulatory body?
If so what checks and balances are necessary
to ensure national regulatory authorities are
responsible for the benefit /risk assurance for
their citizens?
What frameworks are necessary to ensure
vigilance, responsiveness and appropriateness
to different circumstances are maintained?
How will growth be ensured?
 
 
16
 
Conclusion
 
Prioritise the public good
No one can do it alone
Familiarisation with global initiatives is a
MUST
Good regulatory principles still apply – It is
about accurate data, data elements, trust,
responsiveness, sharing, consistency &
transparency
Improve  on  communication and legitimacy
 
17
 
Conclusion cont.
 
Trust is rebuilt by focusing not on what the
other person did or did not do but on
critiquing one's 
own
 behavior, improving one's
trust
worthiness 
and focusing attention not on
words and promises but on actions, attitudes,
and ways of being.
                                          
Kenneth Cloke and Joan
Goldsmith
                                                               
The Art of  waking people up
 
18
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The MCC faces challenges in quality reviews, timeliness, transparency, responsiveness, and capacity. Identified gaps include the regulation of complementary medicines, African traditional medicines, medical devices, and more. Efforts to address these gaps involve the establishment of SAHPRA and initiatives to enhance internal capacity and cooperation with regulatory authorities.

  • Regulatory Oversight
  • Medicines
  • Healthcare
  • SAHPRA

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  1. THE MCC Today and the future Mandisa Hela

  2. Let us recap on OBLIGATIONS Public safety & protection through ensuring efficacy, safety & quality of medicines throughout their lifecycle Risk assessment minimization of harm and maximization of benefit Timely access to medicines & timely action on safety & quality Transparency & accountability Responsiveness Capacity to regulate 2

  3. How is the MCC doing ? Quality of reviews well Members of PICS Supply chain integrity - reasonable Timeliness poor Transparency limited Responsiveness needs improvement Capacity suboptimal

  4. Where did we go wrong ? Current structure conceived more than 40 years ago Over - reliance on external experts Internal technical expertise limited Government department Government implemented pro-access policies without doing an impact assessment, analysing and adapting affected units

  5. Gaps Do not regulate complementary and alternative medicines Do not regulate African traditional medicines Do not regulate medical devices and in vitro diagnostics Do not regulate cosmetics Do not adequately regulate blood products and antivenins Do not adequately regulate adequately starting materials - amending legislation

  6. HOW ARE WE FILLING THE GAPS Establishment of SAHPRA as public entity Regulation of orthodox medicines Regulation of complementary and alternative medicines Regulation of African traditional medicines Regulation of medical devices and in vitro diagnostics Regulation of foodstuffs and cosmetics

  7. How are we filling the gaps ? cont. Increasing internal capacity Numbers Skills base Attitude Improve peer review system frequency of meetings Specialised areas -retainer system Reorganise the appeal process Cooperation with recognised regulatory authorities on cutting edge issues

  8. Current challenges New technologies which respond to conditions exclusively or overwhelmingly prevalent in our country e.g. MDR and XDR TB New type of applicant e.g. Product Development Partnerships Balancing early access to new drugs with the need for comprehensive data Managing newer technologies e.g. biosimilars Managing borderline devices or medicines Maintaining access for older molecules 8

  9. Emerging challenges Regulation of advanced therapy medicinal products Gene therapy medicinal products, Tissue engineered products , biologicals containing GMOs Combined products with devices used as excipients or carriers Emerging / evolving areas e.g. Advanced therapies with accompanying diagnostics 9

  10. What is happening globally? Work sharing among regulators Co-evaluation Abridged methods that avoid duplication of effort In relation to supply chain integrity: electronic symbology initiatives to ensure interoperability of tracking systems across the supply chain Linkage between regulators and Health technology assessment Involvement of the public in regulation 10

  11. What is the way forward ? Co- operation with other regulators is imperative from an efficiency, capacity and responsiveness point of view How? What is in the tool box? What frameworks do we need? Are currently available tools sharp enough? Are they robust enough? What can we adapt to attain a perfect fit to our needs? 11

  12. Food choices

  13. Food choices

  14. Food choices http://t2.gstatic.com/images?q=tbn:ANd9GcQVe04-GZUgNpBcqD0Dv5VXWD6fun8M3jMVRRD25gvNbOOvnx3c

  15. Stepping Stones Shared vision Consistency, transparency and responsiveness Communication, education & training Common standards Enabling Legal instruments Coordination & cooperation Trust & mutual respect A pinch of optimism, an ounce of patience and a healthy dose of perseverance 15

  16. A glimpse into the future Is all this pointing to a global regulatory body? If so what checks and balances are necessary to ensure national regulatory authorities are responsible for the benefit /risk assurance for their citizens? What frameworks are necessary to ensure vigilance, responsiveness and appropriateness to different circumstances are maintained? How will growth be ensured? 16

  17. Conclusion Prioritise the public good No one can do it alone Familiarisation with global initiatives is a MUST Good regulatory principles still apply It is about accurate data, data elements, trust, responsiveness, sharing, consistency & transparency Improve on communication and legitimacy 17

  18. Conclusion cont. Trust is rebuilt by focusing not on what the other person did or did not do but on critiquing one's own behavior, improving one's trustworthiness and focusing attention not on words and promises but on actions, attitudes, and ways of being. Kenneth Cloke and Joan Goldsmith The Art of waking people up 18

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