The portal, which will replace EMA’s online interface EudraPharm, will offer updates on everything from clinical trial information to adverse drug events.
2010 pharmacovigilance legislation, which came into effect in 2012, gave EMA the responsibility of launching such a web portal for medicines, in collaboration with member states and the European Commission.
The legislation also called on member states to launch similar national medicines web portals and the EU-wide portal will link to relevant content on these national web portals, EMA says.
The content of the EU portal will be driven by the legislative requirements, as well as expectations identified within the network and stakeholders’ expectations and needs. Other considerations include making the best use of the available data, how to best search for data and how to ensure that EU citizens can search in their national language as much as possible.
EMA, in collaboration with the member states and the European Commission, will now develop a multiannual delivery plan and start seeking IT solutions to support the project.
“The portal should increase the visibility of information on medicines held by both EMA and the EU Member States. It will also support high-level European initiatives on data availability by providing downloadable, consumable datasets,” EMA said in a consultation adopted by its management board.
As far as challenges, EMA says one of the biggest ones is how best to integrate drug data and document sources feeding the web portal, while providing a meaningful, usable and useful experience for end users.
“Until a full analysis of the technical aspects of this challenge has been undertaken, the extent to which the vision can be achieved, in particular with respect to timelines for finalisation, is difficult to assess with certainty,” the consultation says.
For the portal’s initial launch, EMA says there will be links to the national portal homepages and the medicines search page on these websites in in order to access product information for nationally authorized medicines.
National Competent Authorities will be responsible for the completeness and accuracy of the documents relating to nationally authorized medicines.
In a second phase, the portal is expected to offer additional content and functionality.
“The reliability and searchability of content on the European medicines web portal will be critical to its trustworthiness and success. Poor-quality and unreliable information will undermine confidence in the product and impact the network’s reputation. The issue of poor data quality was identified during the 2010 audit of EudraPharm as one of the interface’s main failings. EMA and NCAs will need to take measures to guarantee the quality of the information they supply to the website in order for the vision to be reached,” according to the consultation.
Development of the European medicines web portal: Reflection paper
EMA Management Board: highlights of October 2016 meeting