Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes-2022/11/18

Scientific guideline: Draft guideline on the development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy-2022/11/18

Scientific guideline: Reflection paper on the criteria to be considered for the evaluation of new active substance (NAS) status of biological substances-2022/11/18

Regulatory and procedural guideline: CAT rules of procedure-2022/11/17

Regulatory and procedural guideline: Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems-2022/11/16

Regulatory and procedural guideline: Procedural advice for orphan medicinal product designation: Guidance for sponsors-2022/11/7

Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes-2022/11/4

Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure-2022/11/4

Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes-2022/11/4

Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure-2022/11/4