Can of worms [Regulatives / Guidelines]

posted by jag009  – NJ, 2020-02-03 19:34  – Posting: # 21135
Views: 599

Thanks Helmut!

Would it make my life easier if a similar study was approved and carried out for the IR counterpart (yes at doses above max total daily dose) many years ago? Both IR and ER (here and other countries that have the ER) have the same max total daily dose limit.

» 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..

Sorry I wasn't specific in previous response. This is a pure exploratory study, not intended for drug submission/registration.

» 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.

So you mean (ok UK is out of the picture I guess in your example?), as an example, apply in Sweden (RMS) and apply to several other countries at the same time?

Thx
J

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