Scientific guideline: ICH reflection paper on proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of

Regulatory and procedural guideline: Guidance on Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period-2023/7/3

Scientific guideline: Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol-2023/7/4

Regulatory and procedural guideline: Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products-2023/6/27

Scientific guideline: Concept paper on the development of a guideline on the quality aspects of mRNA vaccines-2023/6/23

Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes-2023/6/20

Regulatory and procedural guideline: Scientific advice under Art.107(6) of Reg.(EU)2019/6 for establishment of a list of antimicrobials which shall not be used in accordance with Art. 112, 113 and 114 or which shall only be used in accordance with these a

Regulatory and procedural guideline: Guidance on paediatric submissions-2023/6/9

Regulatory and procedural guideline: European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008-2023/5/31

Scientific guideline: Draft ICH E6 (R3) Guideline on good clinical practice (GCP) - Step 2b-2023/5/26