A guide, released today by the European Medicines Agency (EMA), describes 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 in the EU (European Union) on time.
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