EMA: What do I need if I want to run an overdose study [Regulatives / Guidelines]
❝ 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(?)
- EMA: What do I need if I want to run an overdose study jag009 2020-01-28 20:12 [Regulatives / Guidelines]
- EMA: What do I need if I want to run an overdose study Helmut 2020-01-29 16:52
- EMA: What do I need if I want to run an overdose study Ohlbe 2020-01-30 17:32
- EMA: What do I need if I want to run an overdose study jag009 2020-02-03 20:23