E-DRUG: Article of interest - Clinical Trials in Latin America (3)
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Really an excellent work!
On a similar line, a paper was recently published in the BMJ Open, to assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa (Limaye D, Langer JM, Rühling T and Fortwengel G. A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa. BMJ Open 2015; 5(8):e007304.).
The distribution of the market application approvals between the EU/USA as well as India and South Africa revealed that out of clinical trials with the participation of test centres in India and/or South Africa, 39.6% (India) clinical trials and 60.1% (South Africa) clinical trials led to market authorization in the EU/USA without a New Drug Application (NDA) approval in India or South Africa.
The full paper may be accessed at http://bmjopen.bmj.com/content/5/8/e007304
Best regards,
Raffaella
Raffaella Ravinetto
Institute of Tropical Medicine
Antwerpen, Belgium
Raffaella Ravinetto <rravinetto@itg.be>