Ethics for Drugs Testing in Low and Middle Income Countries
Clinical trials are increasingly conducted in low and middle income countries because of lower costs and faster enrolment. Since 2004, the EU has explicitly required that all clinical trials be in accordance with global standards of ethical conduct, whether they have been conducted in the EU or elsewhere, if they are to be taken into account for marketing authorisation. Global standards of ethical conduct are described in the Declaration of Helsinki of the World Medical Association (WMA). Previous reports show that although clinical trial ethics are not always properly regulated or enforced in low and middle income countries, the European Medicines Agency (EMEA) and national medicines agencies of EU member states pay little attention to the ethics of clinical trials conducted in those countries.
Downloaden: Ethics-for-Drugs-Testing-in-Low-and-Middle-Income-Countries (pdf, 666,14 KB)
Downloaden: Ethics-for-drugs-testing-ESP (pdf, 738,70 KB)
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