The European Medicines Agency (EMA) in London is responsible for the Regulatory 
review of new medicinal products for Marketing Authorisation, through which 
pharmaceutical companies may obtain first Marketing Authorisation and subsequent 
Variations valid throughout the EU and EFTA. The qualification opinion of novel 
methodologies is a new procedure where applicants can obtain scientific advice 
on new methodologies for regulatory clinical trials of efficacy of new 
compounds. It will help benefit/risk assessment of the CHMP. The definition of 
prodromal AD is acceptable. The "Dubois Criteria" as criteria to define the 
population must be validated in full at the time of the submission of the 
dossiers. Including a positive CSF biomarker profile is considered predictive 
for the evaluation of the AD-dementia type. However, although high CSF tau and 
low CSF Aβ42 are predictive of Alzheimer's disease, the criterion "positive CSF 
tau/Aβ42 ratio" is not well defined. The qualification of biomarkers in the 
pre-dementia stage of Alzheimer's disease will allow better inclusion criteria 
of patients in pre-dementia trials in which the benefit/risk is higher for 
treatment with these novel compounds.