ICH M12 on drug interaction studies - Scientific guideline-2022/12/12

Regulatory and procedural guideline: Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA-2022/12/12

Regulatory and procedural guideline: ICH guideline Q3C (R8) on impurities: guideline for residual solvents - Step 5-2022/11/28

Scientific guideline: Draft reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations-2022/11/24

Regulatory and procedural guideline: IRIS guide to registration and RPIs-2022/11/21

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