Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)-2023/11/13

Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)-2023/11/13

Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)-2023/11/13

Scientific guideline: Concept paper on the development of an addendum to the Guideline on clinical development of vaccines on clinical trials for vaccines for immunocompromised individuals-2023/11/3

Scientific guideline: Concept paper on the revision of the Non-clinical and Clinical Module of the influenza vaccines guideline-2023/10/31

Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)-2023/10/27

Regulatory and procedural guideline: Procedural advice for orphan medicinal product designation: Guidance for sponsors (updated)-2023/10/20

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)