EU ‘pharma package’ sees big changes for pharmacovigilance

By Phil Taylor

- Last updated on GMT

Related tags Adverse drug reaction European commission

At the heart of Europe’s new ‘pharmaceutical package’ are measures designed to improve patient protection through better safety monitoring.

The package – a bundle of new legislation and guidance aimed at reforming the regulation of the drug industry – also includes measures to combat drug counterfeiting and to allow drugmakers to give information on their products directly to patients through certain specialist sources such as health websites. These were reported last week​.

Commissioner for Enterprise and Industry Guenter Verheugen, who was tasked with bringing the pharmaceutical package into being, said recently that approximately 5 per cent of all hospital admissions in Europe are due to an adverse drug reaction (ADR), and that ADRs are the fifth most common cause of hospital death.

Current measures to monitor adverse drug reactions in the EU “do not sufficiently take into account the different characteristics and risk profile of medicines on the market and do not make best use of knowledge about adverse effects which are occurring​,” according to the European Commission.

The Commission wants to simplify the current procedures, laying out clear roles for member states, the European Medicines Agency and marketing authorisation holders, with the EMEA’s position as the coordinating body “reinforced.”

That will be achieved in part by the formation of a new scientific panel called the Pharmacovigilance Risk Assessment Advisory Committee (PRAAC), which will work alongside the Committee for Medicinal Products for Human Use (CHMP) and representatives from the member states.

Other changes include a revamp of the Eudravigilance database, which should “become the single point of receipt of pharmacovigilance information for medicinal products for human use authorised in the Community​,” and the creation of a new dedicated website to communicate safety issues, according to the Commission.

Package inserts for medicines will also need to be modified to include a ‘key information’ section.

Companies should find their commitment to provide pharmacovigilance information is less onerous because, rather than filing a comprehensive description of the system they intend to use, they will now be able to refer to a pharmacovigilance ‘master file’, analogous to those already used for active ingredients in the EU.


An Impact Assessment carried out for the Commission has estimated that 197,000 deaths per year in the EU are caused by ADRs at a total cost of €79bn. The proposals should save lives and cut the cost of administering the pharmacovigilance system by around €145bn a year, it concluded.

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