The document outlines the regulation of medicines in South Africa. It discusses the key pieces of legislation, the Medicines Control Council (MCC) mandate to regulate medicines, clinical trials, and manufacturers. It also covers flexibilities in the law around access like compassionate use. Current challenges include inspection capacity and emerging areas like advanced therapies. Regulation of biosimilars follows EMA guidelines largely. Global cooperation among regulators is important for efficiency and responsiveness.

1. REGULATION OF MEDICINES
IN SOUTH AFRICA

2. POLICY & LEGISLATIVE FRAMEWORK
 National Drug Policy
 Medicines and Related Substances Act of 1965
to provide for:
- The establishment of the Medicines Control
Council (MCC)
- The registration of medicines and related
substances for human and animal use
- The control of medicines and scheduled
substances
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3. LEGISLATION
Medicines & Related Substances
Act, 1965 (Act 101 of 1965)
 Provides for– Prohibition of sale of medicines which are
subject to registration and are not registered
 Sell means sell by wholesale or retail and includes import,
offer, advertise, keep, expose, transmit, consign, convey, or
deliver for sale, authorise, direct or allow a sale, or prepare
or possess for purposes of sale, and barter or exchange or
supply or dispose of to any person whether for a
consideration or otherwise
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4. MCC MANDATE
 Regulation of medicines based on safety efficacy and quality
 Approval and management of clinical trials
 Pharmacovigilance
 Post- marketing surveillance
 Licensing manufacturers, wholesalers, importers and
exporters
 Provision of information
 Control Aspects: Who may manufacture, distribute,
prescribe, dispense, import, export, etc
 Effective law enforcement
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5. HOW THE MCC WORKS
 Evaluators drawn from Academia, Research Institutions,
Practice settings, very few in-house
 Eight Expert Peer Review committees meet every 4-6 weeks
 GMP / GCP / GWP / GPhP inspections
 Sub committee ad hoc working groups when necessary
 MCC meeting every 6 weeks for decision making
 Registrar keeps register of all medicines
 Registered products and guidelines on MCC website
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6. PRO ACCESS FLEXIBILITIES IN LAW
Provision for
- sale of an unregistered medicine
- Authorisation in writing to a person to sell during a
specified period to any specified person or institution a
specified quantity, for a specific purpose of the use of
such medicine
 Compassionate use
 Investigational drug (Clinical Trial)
 Assumes treating practitioner will monitor patient closely
and motivate why an unregistered medicine must be used
 Patient must be informed that the drug is not
registered and sign informed consent form
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7. PRO ACCESS FLEXIBILITIES IN LAW
cont.
section 15 C
 Enables parallel importation
 Enables compulsory licensing read with Patents Act
 Need for permit and registration
 Read with Patents Act, enables Bolar type provision
Competitions Act prevents abuse of dominance in
relation to intellectual property rights
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8. ACCESS ENABLING CLAUSES
Provision for
 Expedited registration process for medicines on the
Essential Medicines List and
 Medicines containing new chemical entities that are
considered essential for national health
Provision for
-Exclusion of any drug from the operations of Act 101
-
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9. PRESERVATION OF SECRECY
section 34
No person shall, except for
 The purpose of the exercise of his powers
 The performance of his functions
 For the purpose of legal proceedings
 When required to do so by any competent court of
law
 With the written authority of the Director General
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10. PRESERVATION OF SECRECY cont….
Disclose to any other person any information acquired
by him in the exercise of his powers or the performance
of his functions under this Act and
 Relating to the business or affairs of any person
 Or use such information for self-gain
 Or for the benefit of his employer
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11. CURRENT ENABLING REGULATORY
INITIATIVES
 Members of the Pharmaceutical Inspection
Co-operation Scheme (PIC/S)
 Recognise the WHO GMP inspection reports
 Agreement for sharing information with FDA
 Alerts from Europe, FDA & the WHO
 Provide for Abbreviated Medicine Registration Procedure in
the Guideline Documents
 Expert reports on safety efficacy and quality as well as CPP from
countries recognised by the MCC
 Full dossier still required
 Few applicants use it
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12. CURRENT CHALLENGES
 Small country of 50 million people
 Inspection of starting material sites
 Ensuring seamless end to end supply chain tracking
 Experience in inspecting Good Manufacturing Practice
(GMP) in vaccine and other biological product
manufacturing sites – few in-country sites
 Microbiology
 Destruction
 Operator protection
 Cleaning validation
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13. CURRENT CHALLENGES cont.
 Demand for evaluation towards market
authorisation during the development phase –a
first for us
 New type of applicant e.g.
Product Development Partnerships
 Scarcity of resources demands efficiency
 Pressure from a public health perspective to
speed up evaluation without sacrificing safety,
efficacy and quality
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14. 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
companion diagnostics
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15. WHERE ARE WE WITH REGULATION OF
BIOSIMILARS
 Guideline applicable to biological medicines containing well
characterized recombinant DNA-derived therapeutic
proteins that can be shown to be similar to a biological
medicine registered in South Africa
 Largely similar to EMA Guideline in relation to quality, non-
clinical and clinical data requirements
 Risk management plan a requirement
 Not considered to be interchangeable with the reference
product or other medicine of the same class
 Guideline for monoclonal antibodies being finalised for
comment
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16. REGULATORY CHALLENGES WITH
BIOLOGICAL SIMILARS
 Inherent batch to batch microheterogeneity and
variability over time
 Physicochemical and biological characterization
 Post-marketing additional indications
extrapolation
 Changes in manufacturing process
 Is a Biosimilar therefore a Biosimilar forever or
does it have a lifecycle of its own
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17. REGULATORY CHALLENGES WITH
BIOLOGICAL SIMILARS cont….
 Need for factual and unbiased communication on
Biological similars with prescribers and funders
 Information in Biosimilar label for the benefit of
prescribers – how far to go
 Information for patients – how far to go
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18. GAPS
 We do not yet regulate medical devices and in vitro
diagnostics – regulations at drafting stage. Currently
rely on CE mark and appropriate ISO standard.
Regulations at drafting stage.
 We do not yet regulate complementary and alternative
medicines – regulations at drafting stage
 We do not yet regulate African Traditional medicines
 Long evaluation time lines
 Regulator currently being re-engineered to improve
capacity and flexibility
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19. 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
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20. CULTURE
 Does the regulator have a mandate to act on culture and
attitudes ?
 If so, would that be acceptable, permissible or
legitimate?
 If not regulators, who would be responsible?
 There may be compliance with technical and legal
prescripts but if the underpinning values are absent,
short cuts will be found.
 Does our culture as regulators need transformation?
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21. 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?
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22. 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
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23. 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?
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24. 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
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25. END
Ms Mandisa Hela
helam@health.gov.za
South Africa
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