The European Medicines Agency (EMA) has produced a guide on the information the Agency publishes on centrally and non-centrally authorised medicines for human use.
Providing an overview of the range of documents produced by EMA during the life span of a medicine, the guide covers early development, through initial evaluation, adoption of positive or negative opinions, post-authorisation changes and safety reviews.
Details of types of EMA documents, their publication times and where to find them on the EMA’s website are listed in an easy-reference annex.
Stakeholders will also find best-practice advice enabling coordinated, consistent and timely communication activities to ensure that information on medicines is accurate and reaches interested parties on time.
To download the Guide on medicines for human use from the ema.europa.eu website