On 10 October 2016, the European Medicines Agency’s (“EMA”) Management Board adopted a reflection paper on the development of a new European Union medicines web portal. The reflection paper sets out a vision for this new portal and its expected benefits. It also details the means to achieve this vision.

Background

The new portal, taking the form of a multilingual website, is intended to provide wide access to free, reliable and unbiased information concerning all human medicinal products that have been authorised in the European Union (“EU”). It is addressed to patients, consumers, carers, healthcare professionals and academia throughout the EU. It will grant visitors access to comprehensive information on the lifecycle of a medicinal product, from clinical trial information to adverse drug reaction reports.

The development by the EMA, in collaboration with the EU Member States and the European Commission, of a web portal for the purpose of disseminating information on medicinal products authorised in the EU is provided for in Article 26(1) of Regulation (EC) 726/2004 as amended by Regulation (EU) 1235/2010.

The launch of the European medicines web portal

The portal aims to use as a foundation the EudraPharma online database developed by the EMA in 2006 on the basis of Article 57 of Regulation (EC) 726/2004 to make information concerning medicinal products authorised at EU or national level accessible to the public. In a first phase, the new portal will use the data submitted by marketing authorisation holders under the EudraPharma submission process. In a second phase, further content and functionalities will be added to the portal.

Once live, the portal will replace the EudraPharma database and incorporate both the European Database of Adverse Drug Reaction Reports and the EU Clinical Trials Register. It will also include the new clinical data website that is currently being launched and which will make clinical study reports publically available.

In addition to making available information concerning medicinal products authorised at EU level, the European medicines web portal will enable access to product information for nationally authorised medicinal products by providing links to EU Member States’ national web portals. The web portal will increase the visibility of information held by both the EMA and the EU Member States. It should also increase data availability, in support of high-level European initiatives on data-sharing, by providing downloadable, consumable datasets to the portal users.

EMA, in collaboration with the EU Member States and the European Commission, will now develop a multi-annual delivery plan and begin scoping IT solutions to support the project. The National Competent Authorities (“NCA”) will be responsible for the completeness and accuracy of the documents relating to nationally authorised medicinal products. Both the EMA and the NCAs intend to take measures to guarantee the quality of the information supplied to the website. Focus will be put on the reliability and searchability of content in order to ensure the trustworthiness and success of the European medicines web portal.

The reflection paper identifies the biggest challenge as being how best to integrate drug data and document sources feeding the web portal, while providing a meaningful, usable and useful experience for end users. The EMA will operate a full analysis of all technical aspects in order to assess with certainty the extent to which the vision and timelines for finalisation can be achieved.

For further information visit: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2016/10/WC500213925.pdf