Can of worms [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-01-30 12:32 (305 d 20:03 ago) – Posting: # 21103
Views: 2,580

Hi John,

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

No (A)NDAs in Europe. :-D
The equivalent to NDAs are products approved by Directive 2001/83/EC (2001, latest amendment 2012), Articles 8(3) – which amongst others requires clinical studies.
For the equivalent of ANDAs see Article 10(2b).

» 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.

You cannot officially refer by any means to a product which is not on the market. However, the agencies have access to its data. Since the product was taken off the market for safety reasons and you want to go with yours at a higher daily dose it would raise eyebrows at least.

I think that a realistic option is a ‘hybrid application’ acc. to Article 10(3) comparing your ER with the IR product. Then you are free in selecting the dose and regimen of both. Still I have some doubts whether it would be acceptable to go beyond the maximum daily dose of the IR product. Details in the MR guideline Section 5. Additionally to the PK studies (can be a lot: SD/MD, food effect, if different strengths dose-proportionality) clinical studies are required.

Contrary to a generic application where the SmPC (European term for the label) is sufficient, you have to provide a complete IMPD to the IEC and the agency (see the applicable Legislation).

» Question, what's the standard turnaround time? UK?

Bye-bye to the UK on Feb 1st, 00:00… :cool:

» I mean after protocol approved by IRB and going thru the next approval stages(?)

Wait a minute! I’ve been there, done that. Without a scientific advice practically impossible. If you want to be on the safe side, opt for a centralized procedure at the EMA. If you succeed, the product is automatically authorized in all member states. The alternative is the decentralized procedure (DCP): You apply in one country first (the reference member state RMS) with the information that it is not a purely national application but that you will apply in others as well (the concerned member states CMS). Theoretically scientific advice(s) at the RMS sufficient. In tricky cases, I always go to more than one agency (not only the easy ones). Again in theory, once the RMS has accepted your application it has to defend its decision against the CMSs. Does not always work… My current preferred order: Sweden, Denmark, Germany, The Netherlands, Austria. Tricky one: Spain.

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Helmut Schütz
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