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BioAsia Ms. Mandisa Hela - South Africa


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BioAsia Ms. Mandisa Hela - South Africa

  2. 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 substances2
  3. 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 otherwise3
  4. 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 enforcement4
  5. 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 website5
  6. 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 form6
  7. 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 rights7
  8. 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 -8
  9. 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 General9
  10. 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 employer10
  11. 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 it11
  12. 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 validation12
  13. 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 quality13
  14. 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 diagnostics14
  15. 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 comment15
  16. 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 own16
  17. 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 go17
  18. 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 flexibility18
  19. 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 assessment19
  20. 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?20
  21. 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?21
  22. 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 perseverance22
  23. 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?23
  24. 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 legitimacy24
  25. 25. END Ms Mandisa Hela South Africa25