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.

Dear Sparsh,

❝ Dear Sir,

   ▲ … not interested in opinions of female members of the forum?

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

If you want to submit by the Centralised Procedure at EMA a list of authorized products is given here. It’s up to you to find out out which one is the innovator’s product. If no drug is listed there, you may use the innovator’s product marketed in any of the countries of the European Economic Area. It’s up to you to justify why you have chosen a particular reference product/batch (see the BE GL; Section 4.1.2):

The selection of the reference product used in a bioequivalence study should be based on assay content and dissolution data and is the responsibility of the Applicant. […] The Applicant should document how a representative batch of the reference product with regards to dissolution and assay content has been selected. It is advisable to investigate more than one single batch of the reference product when selecting reference product batch for the bioequivalence study.

The same is applicable if you want to go the MRP (Mutual Recognition Procedure) route: National authorisation in one country first (which becomes the RMS = Reference Member State in MRP) and selected members states (CMS = Concerned Member State) later.