IRIS guide to registration and RPIs

ICH E6 Good clinical practice - Scientific guideline

Human medicines European public assessment report (EPAR): Trepulmix, treprostinil, Date of authorisation: 03/04/2020, Revision: 8, Status: Authorised

Paediatric-use marketing authorisations

Human medicines European public assessment report (EPAR): Anoro Ellipta (previously Anoro), umeclidinium bromide,vilanterol, Date of authorisation: 08/05/2014, Revision: 22, Status: Authorised

Human medicines European public assessment report (EPAR): Sugammadex Piramal, sugammadex, Date of authorisation: 23/06/2023, Revision: 3, Status: Authorised

List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products for 2025

Cholic acid product-specific bioequivalence guidance

Dabrafenib product-specific bioequivalence guidance

Veterinary medicines European public assessment report (EPAR): Emevet, maropitant, Status: Authorised