Bioequivalence and Bioavailability Forum

Hi ElMaestro,

❝ Is there anything in the public domain about the threat to prosecute?

Not that I know of. That's what I was told at the time, but I didn't ask for any written source.

❝ Does it mean in the UK you cannot write in a MV for BE or in a BE SR that you comply with GLP?

I don't know what the current status is in the UK.

In France, what I've been told is that GLP inspectors will react if a bioanalytical report of clinical work refers to the French GLP texts which they are supposed to enforce, but will accept a reference to the OECD text. Very hypocritical, considering that the French text is directly derived from the OECD text. I guess that's the compromise that was found between GCP inspectors, who want GLP for BE trials, and the GLP inspectors who don't want to be asked to inspect them.

❝ Also, I think that when regulators can disagree so much in the meaning and interpretation of guidance then there is a clear and present need for a radical update -at least a major revision- of the documents.

It seems to me that the disagreement is not in the meaning and interpretation, but in the contents. The majority voted for something which is not accepted by a minority. The fact that those who disagree most are soon to leave the EU is of little comfort.

❝ No wonder, in light of this, that some companies are very uncertain as to what they need to do in order to comply EU-wide with guidelines.

They will have no problem if they go back to basics. Write what you will do, do as you wrote, write what you did. Qualify your equipment. Use qualified staff. Have a QA in place.