Bioequivalence and Bioavailability Forum

Hi Sparsh,

❝ How to find reference listed drugs (RLD) for submission to EMEA.

This is the slightly wrong question to ask. They have RLD's in the US and the system works in different ways in Europe.
For EU submission (let's call it that in stead of EMEA/EMA submission. The latter would only be CP, and this is rarely what anyone wants for an abbridged dossier) you can copy pretty much any originator drug. As long as you are not conducting BE studies against a 10.1/10.2 or 10.3 approved product you will be in the clear as a general rule, at least when you are not in breach of exclusivity and all that stuff.

Try and read article 10.1 of directive 2001/83. which defines a reference product. You could also surf around on the HMA/CMD(h) websites for things like European reference product, global marketing authorisation etc.