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

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

Guidance on good manufacturing practice and good distribution practice: Questions and answers-2022/10/26

Guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells (updated)-2022/10/26

ICH M11 guideline, clinical study protocol template and technical specifications-2022/10/26

Bioanalytical method validation-2022/10/25

Regulatory and procedural guideline: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes-2022/10/14

Scientific guideline: Reflection paper on criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation (EU) 2019/6-2022/10/14