EU Regulators Tout Progress on Pharmacovigilance Since New Legislation Enacted

Regulatory NewsRegulatory News | 08 August 2016 |  By 

The European Commission (EC) and European Medicines Agency (EMA) say their combined efforts have resulted in improved drug safety monitoring since new legislative requirements went into effect in 2012, according to a report released by the EC on Monday.

"The analysis shows that the new system has been successful at detecting safety issues more quickly, thus enabling regulators to take rapid action when needed and provide advice and warnings to users of medicines," EMA writes, adding that the system "effectively engages patients and healthcare professionals" to report suspected adverse events.

On Monday, EMA also announced that it had moved forward with three of its good pharmacovigilance practice (GVP) guidelines. Specifically, EMA said it had finalized a revision to GVP Module VIII – Post-authorisation safety studies (Rev 2) and its addendum, and had begun public consultations on Module VI – Management and reporting of adverse reactions to medicinal products (Rev 2) and Module IX – Signal Management (Rev 1).


Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. In particular, regulators, companies and healthcare providers are responsible for monitoring drug safety and reporting suspected adverse events.

In 2010 and 2012, the EU introduced new directives and regulations amending its pharmacovigilance requirements, which came into force under the new pharmacovigilance legislation.

Report: Pharmacovigilance 2012-2014

According to the report, the creation of the Pharmacovigilance Risk Assessment Committee (PRAC) and strengthening the Co-ordination group for Mutual recognition and Decentralised procedures – Human (CMDh) were instrumental to improving EU regulators' ability "to take quick and robust" action in response to pharmacovigilance signals.

Between its formation in July 2012 and 2014, PRAC reviewed nearly 1300 risk management plans (RMPs), 193 unique safety signals, more than 900 periodic safety update reports (PSURs) and participated in 31 referral procedures.

Figure 1. PRAC Agenda Items, July 2012-December 2014

PRAC Agenda

According to the report, the number of individual case safety reports (ICSRs) has increased substantially since the new pharmacovigilance legislation took effect.

Figure 2. Individual Case Safety Reports, 2011-2014


The new legislation also required a number of related actions by the agencies, including the creation of the so-called Article 57 database, medical literature monitoring by EMA, as well as improvements to the existing EudraVigilance database.

Additionally, the report highlights EMA's efforts to update and refine its pharmacovigilance guidelines, publish reflection papers on pharmacovigilance related issues and, earlier this year, launched a series of three-day pharmacovigilance courses taking place in across the EU.



Report, Working Document


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy