Bioequivalence and Bioavailability Forum

Hi Dr_Dan,

Greetings from Hamburg, where I hang out today Shouldn't have let my first officer follow his instinct and the polar star.

❝ I know that no “GCP certificates” for BE-centers are issued by EU RAs, however, some (east or south EU) RAs ask for GCP certificates for studies (study centres) included in the dossier for marketing authorization application although there is no legal base for this.

That truly sucks. Hand them an inspection certificate or -in panic situations- an audit certificate and pray.

❝ However, to my knowledge there had been some discussions at EMA whether to issue GCP certificates or not but I do not know the outcome. Someone else?

No idea?!? I could imagine this would have to be escaladed to EU Commission level if it were to become practice. I could imagine we would see a directive amendment as a first sign of something brewing. I think it could quickly go very political, since in some countries the agencies cannot charge for inspections while they can in other countries, and inspection availability ultimately depends on funding.
Another clear answer from ElMaestro... perhaps, no idea, I dunno, yes and no, possibly. And I could be wrong, even when I say "perhaps".