The European Council has adopted a regulation and directive to strengthen the European Union (EU)’s pharmacovigilance system, which monitors the safety of human-use medicines.

Under the new rules, EU member states will be required to collect pharmacovigilance information on suspected adverse reactions (ARs) not only if the product was used within the terms of the marketing authorization (MA) but also in cases of overdose, misuse, abuse and medication errors.

A new pharmacovigilance risk assessment committee will be set up within the European Medicines Agency (EMA, to advise the committee for medicinal products for human use (CHMP) on the risk-benefit assessment of centrally-authorised medicines. The new panel will also advise the EMA’s coordination group on questions related to the pharmacovigilance of all EU-authorised medicines and to any variations granted to the terms of their MAs. Currently, the coordination group examines questions relating to MAs for a product in two or more member states only.

The new rules make provision “to allow adequate funding for pharmacovigilance activities through the collection of fees charged to MA holders for obtaining and maintaining EU MAs and for other services provided by EMA and national competent authorities,” the Council notes.

To facilitate early discovery of ARs, the existing Eudravigilance database will be strengthened and become the single point of receipt of pharmacovigilance information for human-use drugs in the EU, and a new medicines webportal will be set up and maintained by the EMA to ensure transparency in pharmacovigilance issues.

The Council also “invites” the Commission to present an assessment report on the readability of Summaries of Product Characteristics (SPCs) and packaging leaflets and, if appropriate, to table proposals aimed at improving their layout and content.

In future, applications from drugmakers will require them to submit only key elements of their pharmacovigilance systems, rather than a detailed description, but they will have to maintain a detailed file on site for possible inspections.

The Commission will be empowered to require companies to conduct post-authorisation studies on their products’ safety and efficacy, as part of the MA, and the harmonised guiding principles and regulatory supervision will be strengthened to ensure that such studies are non-promotional.

Drugmakers’ periodic safety update reports to EMA will now constitute a scientific evaluation of the product’s risk/benefit balance rather than a detailed presentation of individual case reports - that information will already have been reported to the Eudravigilance database. There may be also a single periodic safety update report for products containing the same active substance or combination but which are subject to different MAs.

Finally, pharmacovigilance for biological products and medicines with a new active substance will be strengthened; their authorisation will be subject to additional monitoring activities and they must be identified by a black symbol and an explanatory sentence encouraging AR reporting o the SPC characteristics and the Patient Information Leaflet (PIL). The competent authorities can also request that this requirement is applied to other products.

These new measures - which were passed by the European Parliament in September after a first-reading agreement and are expected to come into force in 2012 - form the first part of the Commission’s long-delayed package of pharmaceutical legislation to be adopted. The package also includes a draft directive on counterfeit drugs and a draft directive and regulation on information on prescription drugs. The Parliament has now approved the information directive, passing it with major amendments to the Commission’s original proposals, in late November.