EMA Launches Pilot to Gain Better Postmarket Safety Data

The European Medicines Agency is launching a 12-month pilot program to improve the usefulness of postmarket safety data by providing drugmakers with targeted advice on postmarket study design.

Starting in the third quarter of 2015, drugmakers will be able to seek scientific advice from the EMA on protocols for postmarket studies that are not required in their marketing authorization. Drugmakers can seek feedback on study design during any stage of the process from a team from the EMA’s Scientific Advice Working Party and Pharmacovigilance Risk Assessment Committee.

The program is to help companies design trials that are based on sound science and yield robust data, the EMA says, adding the advice will be “prospective in nature” and not specific to any clinical data.

Drugmakers will submit protocols, summaries of product characteristics, risk-management plans and assessment reports. The EMA team will meet with drugmakers to assess the briefing document and answer questions.

Drugmakers will then submit a final study design. Once that is reviewed, a face-to-face meeting with SAWP will be scheduled, resulting in a “final advice letter” 30 days later.  

View the EMA’s guideline on postauthorization procedural advice at www.fdanews.com/07-30-15-PASS.pdf. Information on the pilot program begins on page 146. — Kellen Owings