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THE MEDICINES CONTROL COUNCIL (MCC). Presentation to the Portfolio Committee on Health 24 June 2008. OVERVIEW. Mandate of the MCC Legislative responsibilities Description of the MCC and the cluster Medicines Regulatory affairs Process of evaluation of medicines Fees & timelines
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THE MEDICINES CONTROL COUNCIL (MCC) Presentation to the Portfolio Committee on Health 24 June 2008
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
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
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
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
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
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
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
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
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
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
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
FEES APPLICATION • New chemical Entity – R30 000 • Generic -R12 500 • Major Line Ext. – R20 000 • Minor variation – R230 • Licensing – R3 600
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
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
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
STRATEGIC PLANS • MCC does not have strategic plans • MRA Strategic plans on hard copy • Part of DOH plans
BUDGET 2007/8 • Total allocation R30 554 • MCC R2 397 000 • MRA R28 157 000
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.
