Challenges for European pharmacovigilance Posted 06/09/2019


The European Union (EU) pharmacovigilance system is one of the most advanced worldwide, but challenges remain for the system. Dr Sabine Straus, Chair of the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (EMA) outlined the strengths and weaknesses of the system, and discussed what the future holds for European pharmaco-vigilance, at the 12th Pharmacovigilance Conference in January 2019.

Pharmacovigilance, the process of monitoring the safety of medicines, is a critical part of the drug production process. EMA has a comprehensive pharmacovigilance system which monitors the safety of medicines across the European market, with national reporting systems that allow patients to report adverse drug reactions (ADRs) directly.

The robust legal framework for pharmacovigilance in the EU includes Regulation (EC) No 76/2004 for EU authorized medicinal products and separate Directive 2001/83/EC for nationally authorized medicinal products.

However, there remains room for improvement in the EU system and EMA has been reviewing pharmacovigilance for biologicals and biosimilars. In 2018, they conducted a study to assess how precisely biological drugs were identified in ADR reports from European clinical practice, finding robust levels of product identification but poor batch number identification [1].

Dr Sabine Straus said the strengths of European pharmacovigilance include good monitoring by individual Member States, patient engagement, effective coordination across the EU, high levels of transparency and efficient risk management planning.

However, she also outlined the weaknesses of the system at present, including poor distribution of communications, scientific advice only being sought at a late stage in the process, a lack of funding (and legal imperative) to analyse real-world data, poor connections with healthcare data, and additional procedural complexities.

Looking ahead, the system could be improved by making better use of real-world data to support decision-making, e.g. through acquiring new data sources and methods of analysis, making processes more efficient, and better engaging with the public.

She closed by offering an outlook for European pharmacovigilance over the next two to five years, confirming that in the short term there would remain a focus on process improvement and capacity building, and that all pharmacovigilance activities will continue as normal despite the upcoming Brexit process. Other upcoming initiatives at EMA include a report on Big Data, a new platform for vaccine studies (VACC4EU) and a number of new guidelines (including for geriatrics and pregnancy and revised guidance on risk management).

In the longer term, EMA aims to routinely provide scientific advice based on real-world data, including from patient electronic health records and wearable devices. It also aims to improve its methodology for public engagement, e.g. through public hearings and advisory groups, and to utilise artificial intelligence to enhance its data analysis capabilities.

Related articles
Distinct suffixes will aid biosimilar competition, says new research

How can EU policymakers access the potential of biosimilars

Biosimilars in Europe

1. GaBI Online - Generics and Biosimilars Initiative. EMA studying pharmacovigilance for biologicals and biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 6]. Available from:

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.


Comments (0)