20 May 2016 - New guide to information about medicines evaluated by the EMA.
A guide, released today by the 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.
For more detais, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002532.jsp&mid=WC0b01ac058004d5c1