The European Medicines Agency (EMA) publishes information on human medicinal products at various stages of their life cycle, from the early developmental stages through to EMA’s evaluation of authorisation applications, post-authorisation changes, safety reviews and withdrawals of authorisation. In May 2023 EMA published revised Guide to information on human medicines evaluated by EMA – What EMA publishes and when (EMA/148657/2023).
Document describes the different types of information EMA currently publishes for both centrally and non-centrally authorised medicines, as well as publication times and location on EMA’s website. It aims to help stakeholders know what kind of information to expect on medicines undergoing evaluations and other regulatory procedures. The information described are presented in a tabulated format in the Annex. Whilst reflecting the current practice, the guide is not intended to provide an exhaustive list of EMA publications, and EMA may at its discretion publish additional documents as appropriate. Other non-confidential documents held by EMA which are not published may be provided to stakeholders upon request.
Main changes introduced in the latest revision concern the publication of full risk management plans (RMPs) for certain medicines and publications following plenary meetings of the COMP, CAT and PDCO.
A separate document EMA transparency measures for medicines addressing public health emergencies (EMA/244151/2020) describes additional information EMA publishes in relation to the development, evaluation and supervision of medicinal products for public health emergencies.