EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
EMA Guidance: Post-Authorisation Procedural Advice for Users of the Centralised Procedure
EMA Guidance: Qualification of Novel Methodologies for Drug Development, Guidance to Applicants
EMA Guidance: Pre-Authorisation Procedural Advice for Users of the Centralised Procedure
EMA Guidance: Compilation of Union Procedures on Inspections & Exchange of Information
EMA Guideline: Notification of Serious Breaches or the Cinical Trial Protocol
EMA Guidance: Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period
EMA Guidance: Procedural Advice on Publication on Withdrawals of Applications related to MA
EMA Guidance: Paediatric Submissions Via Syncplicity Web Client
EMA Guidance: Good Practices for Industry for the Prevention of Human Medicinal Product Shortages
EMA Interim Guidance: How to Approach the "PPD and CCI" while using CTIS
EMA Guidance: Pre & Post Authorisation for Users of the Centralised Procedure
EMA Guidance: IRIS guide to Registration and Research Product Identifiers
EMA Guideline: Computerised Systems & Electronic Data in Clinical Trials
EMA Checklist: Updated Validation checklist for Type II quality variations
EMA Guidance: Format & Validity Features of e-Certificates and How to Fll the Application Form
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
EMA Guidance: Pre & Post-Authorisation Procedural Advice for Users of the Centralised Procedure
EMA Guidance: Scientific Advice and Protocol Assistance
EMA Guidance: How to Fill the Application Form for Centralised Type IA and IB Variations