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ICH works on harmonizing data acceptance from multi-regional drug trials

 
• By Vibha Sharma

The International Conference on Harmonisation is working on establishing general principles on how sponsors can plan and design multi-regional clinical trials so as to facilitate the acceptance of data from such studies by multiple regulatory agencies1,2.

The International Conference on Harmonisation is working on establishing general principles on how sponsors can plan and design multi-regional clinical trials so as to facilitate the acceptance of data from such studies by multiple regulatory agencies1,2.

Conflicting regional requirements on data for multi-regional clinical trials currently lead to duplication of unnecessary clinical trials and delay drug development, resulting in inefficiencies in drug development and delays in...

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