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

Regulatory and procedural guideline: Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)-2022/11/4

Scientific guideline: ICH M11 guideline, clinical study protocol template and technical specifications - Step 2b-2022/10/26

Scientific guideline: ICH M11 template - Step 2b-2022/10/26