Mapping of regulatory advice from medicines regulatory network on medicines for human use in the EU

The document explains how regulatory and scientific advice is organised and delivered across the EU medicines network (both EMA and national authorities).
 

Its goal is to:

• describe existing advice pathways
• clarify who does what
• outline ongoing improvements toward better coordination
   

The document maps the main advice tools available to developers:

• EMA Scientific advice (central level), focused on quality (CMC), non-clinical studies
  and clinical development
• National scientific advice provided by individual EU Member State authorities, which can be standalone or coordinated between several countries

Parallel / joint advice, including: 

• EMA + national authorities
• EU regulators + HTA bodies (health technology assessment)
• Specialised advice pathways, including targeted support for: SMEs, advanced therapies (ATMPs), orphan medicines, paediatric development, which often include fee reductions