The European Medicines Agency (EMA) is launching a 12-month pilot to encourage companies to seek scientific advice for post-authorisation safety studies (PASS) for medicines. This voluntary, optional procedure will help to improve the design of studies meant to collect further information on a medicine's safety once it is on the market. This pilot will build on the expertise of the Agency's Pharmacovigilance Risk Assessment Committee (PRAC).

The main focus of the pilot will be non-imposed PASS, i.e. studies which are not a condition to the marketing authorisation.

EMA, through its Scientific Advice Working Party (SAWP), provides scientific advice to companies during the development of their medicines to help them design trials that are scientifically sound and generate robust data for the benefit-risk assessment of medicines. This new scientific advice procedure will systematically involve PRAC. The membership of the SAWP will be extended to include at least two PRAC delegates plus alternates, adding specific expertise in pharmacoepidemiology to the competences of the SAWP. The scientific advice for the PASS protocols will be agreed by the PRAC.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/07/news_detail_002382.jsp&mid=WC0b01ac058004d5c1