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New drug application

Once you have decided to submit a new drug application, use this guide to find out the documents, fees and processing time required to complete the registration.

Full evaluation route for new drug application Follow this guide on the NDA documentary requirements, fees and turn-around-time when registering your therapeutic product via the full evaluation route. Abridged evaluation route for new drug application Follow this guide on the NDA documentary requirements, fees and turn-around-time when registering your therapeutic product via the abridged evaluation route. Verification evaluation route for new drug application Follow this guide on the NDA documentary requirements, fees and turnaround time when registering a therapeutic product via the verification evaluation route.

Last updated: 31 Dec 2018