Marketing authorisation
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This branch covers regulatory writing for authorising human medicines, divided by the application and procedure, the dossier documents, exchanges with the agency and product classes with distinct requirements. Clinical trial documents, pharmacovigilance, general regulatory frameworks, device market access and authorisation of veterinary or other regulated products sit outside this branch.
- Applications and authorisation procedures — European applications and procedures, paediatric plans, early and emergency access, post-approval changes and US new drug applications
- The dossier and its documents — CTD modules and summaries, supporting reports and justifications, product information and packaging text
- Dialogue with the agency — development-stage contact, scientific advice and briefing packages, and responses to questions during review
- Product classes with their own requirements — generics, hybrids, biosimilars, advanced therapies and rare-disease medicines with orphan designation