European medicines regulator sets out plans for revamped drug database

european-medicines-agency-building Canary Wharf

Plans for an electronic database containing information about all human medicines authorised across Europe, which will be accessible to the public as well as healthcare professionals, have been approved by the European Medicines Agency (EMA).

The medicines safety regulator announced on 7 October 2016 that it has agreed the first steps in developing the web portal, which follows European pharmacovigilance legislation requiring the creation of an accessible database, as part of the EMA’s work to protect public health.

As a starting point, the site will contain all the product data provided to the EMA by drug manufacturers as part of the statutory regulatory process. It will also provide links to similar data held by EU member states’ own national medicines safety regulators.

In a paper adopted by the EMA’s management board on 6 October 2016, the EMA explains that the database, which will be multilingual with search and browse options, will be supplemented with additional validated information as it becomes available.

“The vision for the European medicines web portal is to launch a multilingual website for patients and healthcare professionals, as well as other groups or individuals looking for information and data on medicines, such as academic researchers, providing access to information on nationally and centrally authorised medicines for human use in the EU,” the EMA states, adding that the initiative will enhance the reputation of European medicines regulators as providers of “unbiased, up-to-date, trustworthy, scientifically sound and validated online information on medicines”.

The new website will replace EudraPharm11, a website developed by the EMA in 2006 that sought to provide access to information on medicines authorised in the EU.

Last updated
The Pharmaceutical Journal, European medicines regulator sets out plans for revamped drug database;Online:DOI:10.1211/PJ.2016.20201817

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