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

ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals-2022/10/10

Regulatory and procedural guideline: Guidance on parallel EMA / EUnetHTA 21 Joint Scientific Consultation-2022/10/6

Regulatory and procedural guideline: Member states contact points for translations review-2022/10/6

Scientific guideline: ICH guideline E19 on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials - Step5-2022/10/6

Scientific guideline: Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates-2022/10/6