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UK’s Medicine Regulator Initiates New Notification Scheme for Clinical Trials
Sponsors conducting UK clinical trials for medicinal products must adjust to a new notification scheme. The UK’s Medicines and Healthcare Products Regulatory Agency’s (MHRA) new notification system, initiated April 1, is for trials involving medicinal products authorized in any EU member state. Sponsors will receive an acknowledgement letter, after submitting a valid notification, which will act as authorization. The trial may then go ahead after 14 days from receipt of the notification.
International Pharmaceutical Regulatory Monitor |
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