Bioequivalence and Bioavailability Forum

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.