International NDA Clinical Trials in Southeast Asia

Abstract

Participation in international New Drug Application (NDA) clinical trials can bring academic and financial benefits to local doctors, nurses, hospitals, and research institutions. A well developed economy, implementation of International Conference on Harmonization (ICH) Good Clinical Practice, adequate medical and patient resources, local government and regulatory support, reduction of local clinical trial approval time, total patient recruitment time, cost, and high quality results are critical for local doctors or hospitals to be competitive in international NDA clinical trial activities. The requirement for small local clinical trials, which are of no scientific value, for local registration of a new drug should be waived or abolished if possible. Australia is the most successful country and the best example in Southeast Asia for participation in international NDA clinical trials.