Bioequivalence and Bioavailability Forum

Hi ElMaestro,

how did you find this “gem”?

❝ But from the way it is worded I am almost of the impression that the ombudsman has the wrong idea of how scientific advice is usually undertaken and what the purpose is.

Well, it should have taken her max. five minutes to dig this one out.

❝ My own experience is that regulators are fairly good at mentioning very early in SA procedures that it does not involve assessment, and that assessment will only be undertaken after submission (they say/write/express that on a regular basis nationally as well as at EMA).

Not only your experience. From section 23 of the document linked above:

Applicants seeking scientific advice under Article 57-1 (n) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, or protocol assistance under Article 6 of the Regulation on Orphan Medicinal Products (EC) 141/2000 must note that any scientific advice or protocol assistance given is not legally binding with regard to any future marketing authorisation application of the product concerned, either on the Agency/CHMP/COMP, or on the Applicant.
The answer given is based on the question and documentation submitted without prejudice to evolution and developments in the state-of-the-art.
Furthermore, Applicants should note that the advice provided is without prejudice to applicable legislation relating to the particulars and documents, which must be submitted in support of a marketing authorisation application. It is also without prejudice to any intellectual property rights of third parties.
When providing scientific advice or protocol assistance, the CHMP or COMP (for questions related to demonstration of significant benefit within the scope of protocol assistance) do not pre-empt the outcome of the evaluation of any subsequent marketing authorisation application.
Advice will be given in good faith but circumstances could change, especially in the case of early advice or subsequent scientific developments. In some cases e.g. as a result of scientific developments, an alternative approach to that advised may be appropriate. In this case it is recommended to Applicants to request a follow-up to the initial scientific advice or protocol assistance given.
However, where Applicants choose not to apply the advice, they are requested to justify clearly their position in any subsequent marketing authorisation application.

I think the ombudsman didn’t find this document. Otherwise why did she ask “Please provide a statistical overview of pre-submission activities held from 2012-2016 with an indication of the type of pre-submission activity and the type of medicine developer involved…” Well, Section 26:

After each CHMP, an overview of the number of final scientific advice or protocol assistance letters adopted, with broad details on the substance(s) (biological, chemical or other), the intended indication(s), the type of request (new request or follow-up) and the topic (pharmaceutical, non-clinical, clinical or significant benefit) is published in the CHMP Monthly report. The number of new requests accepted by the Committee is provided as well.

Then: “Does EMA charge medicine developers to cover the costs of preparing for and attending pre-submission activities as well as the costs of any follow-up?” I stopped counting the word ”fee” at ~30. Did she look for “costs” only?

❝ Do some of you experts out there see bias arising out of taking scientific advices, or do you have some ideas what the real background of all this is?

No. And no!