EMA Guidance: Application of the Amended Variations Regulation from 1 January 2025
EMA IRIS Guide for Applicants: How to Create, Submit, and Manage IRIS Applications
EMA Guidance: EudraVigilance Registration Manual
New EU Regulations on AI in Medical Devices: Key Insights and Implications
EU Guidance: Procedural Advice on Paediatric Applications
WHO: MeDevIS Platform and EU MDCG Guidance: Classification Rules for IVDs
MDCG Med Dev Guidance: Standardisation for Medical Devices
EMA Guidance: Procedural Advice on Paediatric Applications
EMA Guidance: IRIS Guide for Applicants
EMA Guidance: EudraVigilance Registration Documents
EMA: QRD updation and Product-Information Templates Updation
EMA Guidance: Electronic Submission of Information for Investigational Medicinal Products in XEVMPD
EMA Guidance: Applying for Orphan Designation, IRIS Guide & Orphan Des Procedural Guidance & Forms
EMA Guideline: Notification of Serious Breaches or the Cinical Trial Protocol
EMA Guidance: Procedural Advice on Publication on Withdrawals of Applications related to MA
EMA Guidance: Good Practices for Industry for the Prevention of Human Medicinal Product Shortages
EMA Guidance: IRIS guide to Registration and Research Product Identifiers
EMA Guideline: Computerised Systems & Electronic Data in Clinical Trials
Finland's FIMEA: New/Updated (EU) MDCG Guidances to support Medical Device Operators
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation