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Multi-Regional Clinical Trials: ICH and FDA General Principles for Planning and Design

  • By: Staff Editor
  • Date: April 21, 2017
  • Source: http://www.fda.gov
Abstract:

Multi-Regional Clinical Trials: ICH and FDA General Principles for Planning and Design

With the increasing globalization of drug development, the use of multi-regional clinical trials (MRCTs) for regulatory submissions has increased. Regulatory authorities in different countries such as Japan, USA, EU and China have issued the guidance documents on MRCTs. ICH has started the process for having a harmonized guidance document on MRCTs and the document is likely to be issued in 2017.

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