No chance against RMS? [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2010-08-10 16:26 (4336 d 20:48 ago) – Posting: # 5765
Views: 14,232

Dear Dan,

Under the first point I think I would add that you have not (have you?) received questions for module 3 and specifications; thus, the potential variability from the studies reflects -at least in part- the natural variation within the specifications that the M3 assessor has accepted.

You are right, a referral will not be triggered if the RMS disagrees. This is a new thing and there is very little you can do. If the RMS enforces a principle that has never been defined in a guideline document and which is not in line with contemporary equivalence thinking then honestly I think this would be a case for the European Generics Association. This is a slow process and not one that can be expected to work here and now.
Having said that, I am pretty sure regulators from BfArM are seeing this thread and giving it some consideration. That would potentially be in your favour.

I actually still believe your product is alive.

Pass or fail!

Complete thread:

UA Flag
 Admin contact
22,165 posts in 4,645 threads, 1,572 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time: Saturday 13:14 CEST (Europe/Vienna)

Absolute certainty is a privilege of uneducated minds  and fanatics.
It is, for scientific folk, an unattainable ideal.    Cassius J. Keyser

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