30 years of
GCP quality clinical trials
Large number of experienced trial sites
Clinical Research spending approx US$0.25bn (2002)
English-speaking country
Clinical practices and training most resemble UK/USA Population >
47 million
47.9 million (2007) broad pharmacogenetic mix of race groups
(80% African, 9.6% White, 8.9% Coloured, 2.5% Indian/Asian)
KwaZulu-Natal has
the largest population with 21% and Gauteng 20%
Medicines Control
Council (MCC). Secretariat (MRA) based in Pretoria. Clinical trials
reviewed by external reviewers and MCC’s Clinical Trials
Committee Bioavailability/bioequivalence
studies processed faster by in-house review All reviewer recommendations
must be ratified by Council (8 annual meetings) All trials with
unregistered products and new ex-label indications require MCC
approval Review Cycle: 8-12
weeks (7-14 days for bioequivalence studies)
Why Clinical Trials in South Africa?
