The EMA have notified technical issues with the latest versions (v1.20.0.1) of all four eAFs via the e-submissions website. It is planned to release updated versions with fixes applied, but a release date is not yet available. Regulatory professionals are invited to contact the helpdesk to resolve issues (Link).
Regulatory Outsourcing Options
Cyton’s dedicated regulatory procedures team can support you with:
- Dossier preparation, submission & regulatory procedures
- Regulatory intelligence and strategic planning
- Life cycle management
- Key person cover
- Pharmacovigilance
- Brexit support services