EMA launches post-authorisation safety study pilot

Published: 7-Aug-2015
Regulatory

Encourages pharma companies to seek scientific advice for PASS for medicines


The European Medicines Agency (EMA) has launched a 12-month pilot scheme where it encourages pharmaceutical companies to seek scientific advice for post-authorisation safety studies (PASS) for medicines. This voluntary service aims to help improve the design of studies collecting safety information on medicines that are already being used by patients. EMA will offer advice on appropriate tests and studies.

The agency said the pilot should help design 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'. It added that the scheme would 'foster a more integrated approach to the planning of safety, efficacy and quality studies during the lifecycle of a medicine'.

This pilot will build on the expertise of EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) and will increase its membership on EMA’s Scientific Advice Working Party (SAWP), which liaises with companies seeking advice.

EMA will encourage companies to ask specific questions about the design of their studies at any stage in their development. 'This should result in efficiency gains throughout the process, allow a more intensive interaction with companies and help shorten protocol review times,' said the agency.

  • Companies:
  • EMA European Medicines Agency
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