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

posted by jag009  – NJ, 2020-01-30 04:32 (669 d 18:29 ago) – Posting: # 21100
Views: 3,627

Thanks Helmut!

» First of all: Are you talking about generic application (Directive 2001/83/EC, Article 10(1))? If yes, see below. Otherwise, please provide more details.

No it's not ANDA. Its an exploratory study (NDA?) with an ER formulation

»
» » 1. With a drug that is not approved in Europe …
»
» Showstopper: “… reference must be made to the dossier of a reference medicinal product for which a marketing authorisation is or has been granted in the Union on the basis of a complete dossier in accordance with Articles 8(3), 10a, 10b or 10c of Directive 2001/83/EC, as amended.”

(Sorry I updated my question, there is no question 1 and 2 anymore, just 1 question now)
An IR exists in Europe and an ER also exist in Europe but not the same as my so-called ER product. However, the other Euro ER product has safety issues and is currently off market. Euro IR is ok. I am thinking of dosing the ER of interest at a higher total daily dose than the max recommended dose of the Euro ER that is off the market.

» » What do I need to file?
»
» You need a very (very!) good justification.

Question, what's the standard turnaround time? UK? I mean after protocol approved by IRB and going thru the next approval stages(?)

Thx
John

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