E-DRUG: SA Clinical Trials Guidelines
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Dear E-druggers,
Clinical Trials are a fast growing business in South Africa. For the last 2 years a
working group in the South African Dept of Health has worked on Guidelines for
Clinical Trials. They are based on ICH GCP, Helsinki declaration, and Australian,
New Zealand and Canadian CT guidelines, but specific South African problems, such as
HIV/AIDS, co-morbidity, disadvantaged populations and poor access to anti-retrovirals,
were taken into account.
The Minister of Health recently launched the CT Guidelines, and they are now available
on the Internet. The address is:
Go to Medicines Control Council page. When you have opened the MCC page,
click on the 2 * Clinical Trials and the first three files are component parts
of the clinical trials guidelines.
Comments are welcome, and can be sent to: Nhlanhla Ntuli at NtuliNH@health.gov.za
Regards
Wilbert Bannenberg
WHO Technical Adviser Pharmaceuticals
South Africa
Email: WilbertBannenberg@compuserve.com
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