Bioequivalence and Bioavailability Forum

Dear Dan,

my experience is that most are signed by and MD, but they need not generally be. In some countries they have some funny opinions on that and I guess this is what you are running into here.

Taking it one step further, there is no regulation on what constitutes a clinical assessor. In practice this is a person (or other creature, I do seem to recall cases where I wondered) who assesses module 5 clinical effect and safety and thus comments on the qualifications of the person writing the clin. overview. In some countries, clinical assessors have to be MD's. This as I see it is a turf war: you are not qualified to do that job unless you are an MD. Interestingly, the countries applying such practices (which of course are not written anywhere) have never ever as CMS triggered a referral citing incompetence of a clin. assesor in an RMS even when he or she was not to be considered in possession of the qualifying education as MD. This in practice implies that these countries consider non-MD's incompetent to do such assessments in country X but competent for assessment in countries Y and Z.

Dear HS,

my mother tongue is not German, it is ... erm ... Flemmolophystic or what the heck it's called here in Belgium ?
I think the paragraph you are referring to has another practical meaning. It basically says that the application must contain a review of the CMC, the preclinics, and not least the clinics, for which the documentation is to be produced by qualified personnel.
IOW, it comments on the qualification on the personnel who produce module 5 contents (clin. study reports), but not on the qualifications of the reviewing personnel who produce the overview. Setting specifications for investigators etc is common and a requirement in accordance with the general GCP regulation, see e.g. ICH E6 8.2.10, 4.1.1 and 3.1.3.