EMA: What do I need if I want to run an overdose study [Regulatives / Guidelines]

posted by jag009  – NJ, 2020-01-28 21:12 (1036 d 11:48 ago) – Posting: # 21092
Views: 4,743

Hi all,

Need some help with running studies in Europe. If I want to run a PK study under each of the two scenarios:
  1. With a drug that is not approved in Europe but approved in USA, and i want to dose at a total daily dose higher than the total daily dose per label in USA.
  2. With a drug that is approved in Europe but at a higher total daily dose than that on the label.
What do I need to file? I know in US I need IND, in Canada I need a full CTA (30 days). what about in Europe? how long?

Thx
J

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