Bioequivalence and Bioavailability Forum

MA (EU) vs. ANDA (USA) [Design Issues]

posted by Helmut  – Vienna, Austria, 2010-01-20 19:18 (5995 d 20:15 ago) – Posting: # 4626
Views: 8,174

Dear Raghavender!

❝ Nowadays, Sponsor's initially submit the ANDA submission to the proposed countries (EU),

In the EU the sponsor applies for Market Authorization (MA) - ANDA is FDA's term.

❝ Later on they might submit to the rest of the world.

Well, except to the FDA (unless you have included FDA's RLD in a 3way-study).
Some countries except the European reference product if it can be demonstrated that the reference product in that particular country is similar (based on in vitro data), whilst other require the innovators product marketed in their country as a reference anyhow.
This was the driving force behind WHO's 'International Comparator' - but I'm afraid it didn't work out.

❝ If any query comes after several years, then it would be difficult to answer and product approval may be questionable ???

You are right.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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