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European regulators give new medicines portal the go-ahead

EMA sets out plans for new online resource for patients, HCPs and academia 

EMAThe EMA has given the green light for the development of a new online resource for patients, consumers, carers, healthcare professionals and academia.

The European medicines web portal will be a multilingual website offering "free, reliable and unbiased information" on all medicines authorised in the EU.

This will be provided for a medicines entire lifecycle, from clinical trial information to adverse drug reaction reports, aiming to make it more visible.

Around three-quarters of the 508 million people in the European Union have access to the internet at home, many of whom use it for medical and health information.

The go-ahead for the new portal was agreed at a meeting last week of the EMA Management Board and setting out its vision for the new website the board said it would "provide a unique source of information on all medicines authorised in the EU".

"The website will help to position the EU medicines regulatory network as a core provider of free, unbiased, up-to-date, trustworthy, scientifically sound and validated online information on medicines, and will provide access to nationally authorised product information in a phased approach."

The information it provides will, the EMA said, comply with the HONcode standard for trustworthy health information and be accessible on both mobile devices and desktops.

Once live it will replace the EudraPharm online medicines database that the EMA developed in 2006 and incorporate both the European Database of Adverse Drug Reaction Reports and the EU Clinical Trials Register.

It will also swallow up the forthcoming clinical data website, which will be launched later this month to make clinical study reports externally available.

The web portal is a requirement of the 2010 pharmacovigilance legislation that came into effect in 2012 and marked the biggest changes to European regulations since the EMA was set up in 1995.

The EMA Management Board noted in a 'reflection paper' it signed off last week that the 2010 legislation also gave EU member states "the obligation to launch similar national medicines web portals".

The next steps for the European web portal will see the EMA collaborate with EU member states and the European Commission to develop a delivery plan and start scoping IT solutions it will need to support the project.

10th October 2016

From: Marketing



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