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.
This guide describes the different types of information the Agency 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 in this document is 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 nonconfidential documents held by EMA which are not published may be provided to stakeholders upon request.
A separate document describes additional information EMA publishes in relation to the development, evaluation and supervision of medicinal products for public health emergencies.
This guide was last updated in July 2025. The changes introduced concern:
• Section 2.4 Re-examination of opinions: the text referring to the original refusal Q&A being linked to the CHMP highlights has been removed; in addition, the text related to the re-examination of positive opinions has been clarified.
• Section 3.2 Other variations, annual re-assessments, renewal and line extensions: it is clarified that summary of opinions are also published when a significant change in the number or frequency of doses is introduced.