1. THE MEDICINES CONTROL COUNCIL (MCC) Presentation to the Portfolio Committee on Health 24 June 2008

2. OVERVIEW  Mandate of the MCC  Legislative responsibilities  Description of the MCC and the cluster Medicines Regulatory affairs  Process of evaluation of medicines  Fees & timelines  Strategic plans  Budget

3. MCC MANDATE  Registration of medicines based on quality efficacy and safety (human & veterinary)  Approval of clinical trials  Monitoring of safety  Response to signals  Licensing manufacturers, wholesalers and distributors  Provision of information  Timely access to medicines

4. LEGISLATIVE RESPONSIBILITIES  MINISTER: Appointment of MCC, Appeal Committee against decisions of the MCC and DG, Appointment of registrar and deputy registrar/s, Promulgation of regulations in consultation with MCC, grants exemptions to some sections of the Act in consultation with MCC, determines fees in consultation with Minister of Finance  DIRECTOR GENERAL: Release of Information, Issuing of Permits for Psychotropics & Narcotics, Licensing premises, appointment of law enforcement inspectors, appointment of secretariat to MCC, collection of fees

5. LEGISLATIVE RESPONSIBILITIES cont.  MEDICINES CONTROL COUNCIL: Approval of Medicines, Licensing of Manufacturers, Distributors & Wholesalers, Registration of Medical Devices, Regulation of Clinical Trials etc  REGISTRAR OF MEDICINES : Registration, Secretary executive functions, Delegated authority, licensing, etc  INSPECTORS: Law enforcement, Entry, Search and Seizures, Taking samples & conducting tests

6. HISTORY  Human medicine regulated for past 41 years  Veterinary medicines regulated since 1947 under Act 36 but brought under the ambit of MCC in 1979  Stock remedies still regulated under Act 36 administered by the department of Agriculture

7. HOW THE MCC WORKS BY LAW  Obliged to hold at least one meeting every two months  Provision for special meetings at the discretion of the chairperson or on request by at least 3 members  On request by Minister  Decisions are by majority vote except S36 exclusions when a unanimous decision is required  Executive committee may exercise all powers of council in between meetings, subject to ratification at first ensuing meeting of council

8. HOW THE MCC WORKS cont.  24 Council members with defined expertise and skills  10 technical Expert committees, varying in numbers from 7 to 22 members  145 members total currently  Academic, research and professional backgrounds  Drawn from various institutions throughout the country

9. HOW MCC WORKS

10. MEDICINES REGULATORY AFFAIRS CLUSTER (MRA)  Secretariat to the MCC  All employees of Department of Health  Four directorates viz:- Medicines Evaluation & Research (includes Complementary and African Traditional Medicines), Clinical evaluations and Clinical trials (includes pharmacovigilance), Inspectorate(GMP,GCP,GWP,GDP) & law enforcement and Operations & Administration

11. MRA cont.  Each directorate supports one or more expert committees  Staff complement of 138, comprising 74 technical (health-related) - -3 doctorate -11 masters -2 studying masters -1 studying doctorate -Rest 1st degree qualification

12. MRA cont.  Inspectorate – Good manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP) – peer reviewed by P&A Committee  Licensing manufacturers (currently about 200, wholesalers (about 120 more to be inspected)  Another 180 manufacturing sites abroad  Law Enforcement – including International Narcotics Board (INCB) issues, Permits in accordance with section 22A of the Act etc  Analytical laboratories outsourced

13. PROCESS OF EVALUATION  Applications screened by secretariat  New chemical entities, clinical trials reviewed by external evaluators  Report peer reviewed by relevant expert committee  Some internal review for generics (pharmaceutical and analytical, bioequivalence, post –registration minor amendments, standard package inserts - all subject to peer review  Committees recommend to MCC for marketing authorisation or rejection

14. FEES APPLICATION  New chemical Entity – R30 000  Generic -R12 500  Major Line Ext. – R20 000  Minor variation – R230  Licensing – R3 600

15. FEES CONT.  Retention Fees – R550 pa  Fast track application –R5 000  Registration – R600  Section 21 Exemptions – R200  Collect about R20 million to R25 million pa  Transferred to the Treasury at end of financial year

16. TIMELINES  FAST TRACK 9-15 months  Generics 18-24 months  NCEs 24 –36 months  Clinical trial approval 12 – 16 weeks on average No “stop-clock” policy

17. TIMELINES cont.  Fast track should be 9 months  NCE in mature Regulatory authorities 12 months (TGA Australia, Canada, MHRA Britain, FDA USA)  Generics – 3months  Clinical Trials – 4 -6 weeks  All with stop-clock policy

18. WORKLOAD TRENDS Recvd200220032004200520062007 NCE293162414942+ 12(b) Generic496555647564886912 Total552634718613940966 Fast Tr.4977104125197222 Registe red 427445292769551387

19. CLINICAL TRIALS 2004200520062007 Recvd258269264 Apprvd225240227 Canc.82113 PhaseIV2100 Rejected265 Not apprvd 220

20. STRATEGIC PLANS  MCC does not have strategic plans  MRA Strategic plans on hard copy  Part of DOH plans

21. BUDGET 2007/8  Total allocation R30 554  MCC R2 397 000  MRA R28 157 000

22. BUDGET-MCC & MRA  Budget 2008/9 R36.503 million  MCC experts remuneration category A committee per Treasury definition –R3.5 million  Appointing about 10 to 15 additional  Professional staff R18.64 million  Administrative staff R3.071  Inspections-R4.5 million  Balance admin, stationery, courier, office equipment, airfares, hotel for experts etc.

23. MCC RATES(pa –FTE) MCCR / annumR/dayR/hour Chairperson758 5773011377 Vice-chair644 5802558320 Member564 2552240280 Committees Chairperson673 8422674335 Vice-chair572 6582273285 Member531 8672111264

24. EXPENDITURE 2007/8 ITEMBUDGEXP 000 COM 000 EXP%BAL 000 Comp19579259540132.6-6375 Goods10767136771208138.5-4118 Equip5182623457.14222 Levies0000 House0380-38 Total308641242133.4- 10309

25. EXPENDITURE MCC ITEMBUDG ET EXP 000 COM 000 EXP%BAL 000 Comp157527180172.6-1143 Goods & Serv 822206413252.7-1255 Total2397478213200-2398