EMA Will Monitor 400 Drug Substances for Adverse Reactions

The EMA plans to screen medical literature to identify suspected adverse reactions with 400 active substances authorized in the EU.

The project will kick off July 1 with the monitoring of 50 substances and will be rolled out fully by September. The 400 targeted substances were chosen because of the frequency with which they appear in authorized medicines, the EMA says. Data gleaned from the effort will be entered in the EudraVigilance database.

The project is expected to benefit more than 4,000 companies by relieving them of the job of monitoring the medical literature for these 400 substances. They will, however, still need to monitor the literature for side effects related to other drugs.

Other expected benefits of the project include enhancing the quality and consistency of adverse event data, reducing the number of duplicate reports and conserving industry resources, the EMA says.

The project is in line with guidance from Good Pharmacovigilance Practices Module VI.

Other authorized groups that are not associated with the EMA will be required to monitor scientific literature and report on adverse reactions to substances other than the 400 on the EMA’s list. — John Bechtel