Both national and central scientific advice are important mechanisms to gain feedback from competent authorities during drug development.

Your choice of adviser is highly dependent on your type of product, the stage of development, your budget and how much time you have at disposal. Today we are sharing a shortlist that might be helpful when planning for EU scientific advice:

National advice from Swedish MPA

– Characterized by openness and dialogue.

– Face-to-face/online meeting or written advice

– Meeting minutes are written by the applicant and reviewed but not formally approved by the MPA. 

– Non-binding

– National view

– Quicker (2-4 months)

– Low cost (~€ 6000)

Central advice from EMA (CHMP)

– More bureaucratic procedure

– Preparatory meeting encouragedFormal written advice (issued by the CHMP)

– Non-binding

– Pan-European view

– Slower (4–6 months)

– Expensive (€51,800 to €103,800) but 90% fee reduction for SMEs

Would you like to know more? Contact us at info@regfile.se.