1. The South African perspective
PHARMACOVIGILANCE
The South African perspective

2. Medicine Control Council
The Medicines Control Council of South Africa is an independent and impartial statutory body tasked with the regulation of medicines based on quality, efficacy and safety in terms of the Medicines and Related Substances Control Act (Act 101 of 1965).

3. MEDICINES CONTROL COUNCIL
Responsibility for approving medicines for use in South Africa and the control thereof
Sect 1(3) “In determining whether or not the registration or availability of a medicine is in the public interest, regard shall be had only to the safety, quality and therapeutic efficacy thereof in relation to its effect on the health of man or any animal, as the case may be”

4. Medicine Control Council
Dept Of
Health
Inspectorate
Medicine Regulatory Affairs
Clinical
Evaluation
&
Trials
Directorate
Ops &
admin
Pharm &
analytical
Committee
10 different

5. COMMITTEES OF COUNCIL Clinical Committee
Pharmaceutical and Analytical Committee
Clinical Trials Committee
Biologicals Committee
Veterinary Clinical Committee
Scheduling Committee
Complementary Medicines Committee
African Traditional Medicines Committee
Pharmacovigilance Committee
Veterinary Policy Committee
AIDS Vaccine Task (Sub Committee of CTC)

6. REGISTRAR/ CLUSTER MANAGER GMP Finance Clinical Secretary&
Administration
Medicine
Evaluation
& Research
Clinical
Evaluation
& Trials
Operations
&
Administration
Inspection
&
Law Enforcement
GMP
Pharmaceutical
Analytical
Amendments
Council
Support
Finance
Licensing
Biological
Information
management
Veterinary
Clinical
Trials
Law
Enforcement
Scheduling
Complementary
medicines
Pharmaco-
vigilance
Clinical
HIV Vaccine

7. STAFFING OF THE PHARMACOVIGILANCE CENTRES LATE NINETIES

8. National DRAs and Pharmacovigilance ministry of Health Centres Uppsala
Complementary
Medicines
Clinical
Trials
Inspectorate
Uppsala
Monitoring Centre
MCC
NADEMC
UCT teaching
hospital
Public
health
Clinical
Consulting
Healthlink
SAMJ/SAPJ
TRAMED
MIC
Teaching
Industry
SAMF

9. Selected reports to WHO Manufacturer & reporter informed
ADR forms distributed
feedback
Reports submitted to NADEMC
Entered into database
Receipt acknowledged
Evaluation Process
ADRs presented to MCC
Selected reports to WHO
Manufacturer & reporter informed
Published in SAMJ
Action taken by manufacturer

10. National Pharmacovigilance Collaborating Centres
MRA, MCC,
DOH (Dissemination of information to clinicians and other Health care Providers.
The Medunsa Pharmacovigilance Centre (MPC).
Adolescence and Adults
The Bloemfontein Pregnancy registry and pediatric monitoring centre.
National Adverse Drug Event Monitoring Centre (NADEMC) - UCT

11. STAFFING OF THE PHARMACOVIGILANCE CENTRES CURRENT

12. Reporting of Adverse Reactions
To report an Adverse Drug Reaction, fill out the yellow ADR/product quality reporting form. The form can then be sent either to the
Registrar of Medicines, private bag x828, Pretoria, 0001, Tel: , fax: OR
The National Adverse Drug Event Monitoring Center (NADEMC)
C/o Division of pharmacology, UCT,Observatory, Tel: , Fax
To order more yellow forms for your institution, contact the above addresses.
There has been inadequate spontaneous reporting of ADRs from clinicians nationwide. ADRs can be reported either by fax, , telephone or mail by any health care provider to either the reporting center at UCT or directly to the Medicines Control council (MCC). Aggregate reporting from all over the country will assist in improved patient management and medicine regulation.

13. Bloemfontein Pharmacovigilance unit
Monitoring of ARV’s in pregnant women and paediatric patients.
Establishing a pregnancy registry.

14. Medunsa Pharmacovigilance Unit
Youth and
Adult Monitoring of ADR with a focused surveillance to the Antiretrovirals

15. Satellite units Satellite units
Dean and head of school
Advisory Board
Director of Pharmacovigilance unit
Finance committee
Management committee
Pharmacovigilance
centre
Satellite units
Satellite units
Satellite units

16. Pharmacovigilance and Public Health:
The Medicines Act makes provision for the mandatory reporting of adverse drug reactions by the pharmaceutical industry. This has not been the case for health professionals therefore the culture of spontaneous reporting has generally been low in South Africa as evidenced by the low rates in the past.

17. Adverse Drug Reaction Reporting Rates in S. Africa
No. of Reports
Reporting Year

18. Thank You
Rajen Misra
MbChB;D.For.Med;MFGP;M.ClinPharm
Director :Clinical Evaluations & Trials, MRA,NDOH