This validation checklist is used by the Agency to validate initial marketing authorisation applications for pharmaceuticals and applicants should use it as a means to review in advance of their submission that standard requirements are fulfilled.
News & Trends
Procurar
Recentes
- Validation checklist for initial MAA under Regulation (EU) 2019/6 – biologicals other than immunologicals
- MDCG Guidance Update : Classification of Medical Devices – Revision 1
- AI Regulation in Pharmacovigilance. REGULATORY BRIEFING 2026
- ICH Quality Risk Management as part of Integrated Quality Management
- FDA Examples of Real-World Evidence Used in Medical Device Regulatory Decisions
- FDA eMDR – Electronic Medical Device Reporting
- ACT EU Draft Guidance on Clinical Trials During Public Health Emergencies
- EMA’s ePI Roadmap