Signal Management: EMA and EC agree to further extend the Pilot

During a pilot period which started in February 2018, Marketing Authorization Holders (MAHs) of active substances included in the EMA list of active substances and combinations have to monitor them in EudraVigilance and inform EMA and national competent authorities of validated signals with their medicines. The European Medicines Agency (EMA) and the European Commission (EC) have now agreed to further extend the pilot on signal detection until the end of 2022.

MAHs with APIs included in the EMA list of active substances involved in the pilot should continue to monitor them in EudraVigilance. All other MAHs also have access to EudraVigilance and can integrate data into their own signal management processes / systems. However, during the pilot they will have no obligation to continuously monitor EudraVigilance and inform the regulatory authorities of validated signals from EudraVigilance. These transitional arrangements do not apply to obligations on simplified reporting and management of individual case safety reports.

What is a safety signal?

According to the EMA, a safety signal is "information on a new or known adverse event that may be caused by a medicine and requires further investigation". The EMA, together with the regulatory authorities in the Member States and MAHs are responsible for detecting and managing these safety signals. "The evaluation of safety signals is part of routine pharmacovigilance and is essential to ensuring that regulatory authorities have the most up-to-date information on a medicine's benefits and risks". Safety signals can be detected from a wide range of sources, such as

• spontaneous reports,
• clinical studies,
• scientific literature.

EudraVigilance is an important source of information on suspected adverse reactions (SARs) and signals. However, the "presence of a safety signal does not directly mean that a medicine has caused the reported adverse event. An illness or another medicine taken by the patient could also be the cause. The assessment of safety signals establishes whether or not there is a causal relationship between the medicine and the reported adverse event".

More detailed information is available under Signal management on the EMA website.