EMA to encourage use of scientific advice for post-authorisation safety studies

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EMA to encourage use of scientific advice for post-authorisation safety studies

12-month pilot will support design of high-quality safety studies

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.

The PRAC currently endorses the protocols of imposed PASS studies and can review protocols of non-imposed PASS. With this pilot, EMA is offering an additional option for companies to ask specific questions on the design of their studies through scientific advice earlier on, or at any other stage of the development of the protocol of these studies. This should result in efficiency gains throughout the process, allow a more intensive interaction with companies and help shorten protocol review times.

In this pilot, requesting scientific advice should assist the developers in putting together safety studies which are of high quality and can provide useful information on a medicine in a real-life setting, in the interest of patients. Overall, the pilot will foster a more integrated approach to the planning of safety, efficacy and quality studies during the lifecycle of a medicine.

EMA is publishing updated questions and answers to give more details on this procedure, as well as the letter of intent companies should send to the Agency to submit a request for scientific advice.

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