EMA Guidance: Application of the Amended Variations Regulation from 1 January 2025
EMA Guideline: Quality and Equivalence of Locally Applied, Locally Acting Cutaneous Products
EMA IRIS Guide for Applicants: How to Create, Submit, and Manage IRIS Applications
EMA: Harnessing AI in Medicines Regulation: The Role of Large Language Models (LLMs)
EMA Guidance: EudraVigilance Registration Manual
EMA Guidance: Proposed Amendments - Variations Categories and Procedures
EMA Guidance: Procedural Advice on Paediatric Applications
EMA Guidance: IRIS Guide for Applicants
EMA Guidance: EudraVigilance Registration Documents
EMA: Guidance on the Anonymisation of PPD & Assessment of CCI during the preparation of RMPs
EMA Guidance: Real-World Evidence for supporting Regulatory Decision-Making
EMA: Guidance on the Pharmaceutical Quality of Inhalation & Nasal Medicinal Products
EMA Guidance: e-Submission of Information on IMP in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
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 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
EC Q&A Guidance: Questions & Answers: Clinical Trials Regulation