Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)-2023/9/29

Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)-2023/9/29

Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of depression - Revision 3-2023/9/15

Draft Guidance: Clinical Pharmacology Considerations for Peptide Drug Products-2023/9/8

Scientific guideline: DRAFT qualification opinion for GFR slope as a Surrogate Endpoint in RCT for CKD-2023/9/6

Regulatory and procedural guideline: Member states contact points for translations review (updated)-2023/8/30

Regulatory and procedural guideline: Guidance to applicants/marketing authorisation holders on oral explanations at European Medicines Agency-2023/8/8

Regulatory and procedural guideline: Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP) (updated)-2023/8/1

Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)-2023/7/31

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 (updated)-2023/7/31