Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)-2022/12/21

Risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products - Scientific guideline (updated)-2022/12/19

Scientific guideline: Concept paper on a guideline on risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products-2022/12/19

Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated)-2022/12/16

Scientific guideline: Liposomal amphotericin B powder for dispersion for infusion 50 mg product-specific bioequivalence guidance-2022/12/16

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