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