Scientific guideline: Guideline on the calculation of dose factor to be submitted to the Union Product Database (UPD)-2023/10/13

ICH guideline E19 on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials - Scientific guideline (updated)-2023/10/6

Regulatory and procedural guideline: Guidance on handling scientific committee/other (scientific) expert group member’s declared intention to become an employee in a pharmaceutical company, a medical device company or in the biotechnology sector (updated)

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Draft Guidance: Clinical Pharmacology Considerations for Peptide Drug Products-2023/9/8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