The new EU Clinical Trials Regulation No: 536/2014

Replacing the current Clinical Trials Directive

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On 16 June 2014, the Clinical Trials Regulation (536/2014) entered into force. This Regulation will replace the current Clinical Trials Directive 2001/20/EC which has contributed to a significant drop in the number of clinical trials conducted in the EU.

ASEAN Common Technical Dossier (ASEAN CTD or ACTD)


ASEAN is a geo-political and economic organization of ten countries located in Southeast Asia, which was originally formed on August 8, 1967 by Indonesia, Malaysia, Singapore and Thailand. Since then the membership has extended to Brunei, Myanmar, Philippines, Cambodia, Laos PDR and Vietnam. As of 2012 the ASEAN region has a population of about 600 million and combined gross domestic product of PPP (Purchasing Power Parity) US$3.62 trillion.