Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure-2023/4/25

Regulatory and procedural guideline: Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to

Scientific guideline: Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation-2023/4/21

Regulatory and procedural guideline: IRIS guide to registration and RPIs-2023/4/20

Regulatory and procedural guideline: Amended Biologics Working Party (BWP) Ad hoc Influenza Working Group - EU recommendations for the seasonal influenza vaccine composition for the season 2023/2024-2023/4/20

ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products - Step 2b - Scientific guideline-2023/4/20

Regulatory and procedural guideline: Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group-2023/4/19

Scientific guideline: Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates-2023/4/5

Scientific guideline: Questions and answers on data requirements when replacing hydrofluorocarbons as propellants in oral pressurised metered dose inhalers-2023/4/5

Scientific guideline: Guideline on influenza vaccines – submission and procedural requirements (Rev.2)-2023/4/3