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

posted by jag009  – NJ, 2020-01-30 03:32 (306 d 04:24 ago) – Posting: # 21100
Views: 2,562

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

Complete thread:

Activity
 Admin contact
21,224 posts in 4,427 threads, 1,481 registered users;
online 13 (0 registered, 13 guests [including 4 identified bots]).
Forum time: Tuesday 07:56 UTC (Europe/Vienna)

The fundamental cause of trouble in the world today is
that the stupid are cocksure
while the intelligent are full of doubt.    Bertrand Russell

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5