Bioequivalence and Bioavailability Forum

Hi John,

❝ Need some help with running studies in Europe.

When I read your post I interpreted it differently than Helmut and ElMaestro. So could you clarify your question: would you run those studies to register your drug in Europe, or to register it in the USA ? Helmut and ElMaestro answered with EU registration in mind, I understood you were asking about the authorisation of the studies.

❝ What do I need to file? I know in US I need IND, in Canada I need a full CTA (30 days). what about in Europe? how long?

CTA-like. You need an authorisation from the competent authority of the Member State where you would be running the trial + Ethics Committee opinion. You can submit to the authority and to the Ethics Committee in parallel. Timelines: supposed to be 60 days max + questions, according to Directive 2001/20/EC. Could be shorter depending on the Member State. Longer for products of biological origin. I can't say about the UK (especially after this week).

More details available in Eudralex volume 10. See for instance:

• Guidance for the request to the Competent authority (CT-1)
  
• Guidance for the application to the Ethics Committee
  
• Guideline for the IMPD

These are national procedures - so you can expect some differences in the way it has been transcribed into national legislation, from one country to the next.

Being based in the USA, you would need a legal representative in the EU.

❝ An IR exists in Europe and an ER also exist in Europe but not the same as my so-called ER product. However, the other Euro ER product has safety issues and is currently off market. Euro IR is ok. I am thinking of dosing the ER of interest at a higher total daily dose than the max recommended dose of the Euro ER that is off the market.

You will need to justify in your protocol (subject safety) and plan the monitoring of the subjects accordingly.