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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 - PowerPoint PPT Presentation
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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
HOW MCC WORKS
MEDICINES CONTROL COUNCIL
Clinical Committee
PharmacovigilanceCommittee African Traditional
Medicines
Complementary medicines
Scheduling Committee
Biological Committee
Pharmaceutical& Analytical
Clinical TrialsCommittee
HIV Vaccine trials Committee
Veterinary ClinicalCommittee
Registrar
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
WORKLOAD TRENDSRecvd 2002 2003 2004 2005 2006 2007
NCE 29 31 62 41 49 42+
12(b)
Generic 496 555 647 564 886 912
Total 552 634 718 613 940 966
Fast Tr. 49 77 104 125 197 222
Registered
427 445 292 769 551 387
CLINICAL TRIALS2004 2005 2006 2007
Recvd 258 269 264
Apprvd 225 240 227
Canc. 8 21 13
PhaseIV 21 0 0
Rejected 2 6 5
Not apprvd
2 2 0
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.
MCC RATES(pa –FTE)MCC R / annum R/day R/hour
Chairperson 758 577 3011 377
Vice-chair 644 580 2558 320
Member 564 255 2240 280
Committees
Chairperson 673 842 2674 335
Vice-chair 572 658 2273 285
Member 531 867 2111 264
EXPENDITURE 2007/8ITEM BUDG EXP
000COM 000
EXP% BAL 000
Comp 19579 25954 0 132.6 -6375
Goods 10767 13677 1208 138.5 -4118
Equip 518 262 34 57.14 222
Levies 0 0 0 0
House 0 38 0 -38
Total 30864 1242 133.4 -10309
EXPENDITURE MCCITEM BUDG
ETEXP 000
COM 000
EXP% BAL 000
Comp 1575 2718 0 172.6 -1143
Goods & Serv
822 2064 13 252.7 -1255
Total 2397 4782 13 200 -2398
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