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

IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants-2022/10/11

Scientific guideline: ICH: S 1 B 9R1): Testing for carcinogenicity of pharmaceuticals - Step 5-2022/10/10

Regulatory and procedural guideline: Data Quality Framework for EU medicines regulation-2022/10/10

Scientific guideline: ICH: Q5A(R2): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Step 2b-2022/10/10

ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Scientific guideline-2022/10/10