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EU Clinical Trial Regulation

Judge backs HRA in transparency legal case

Gavel
The HRA's plans for greater pharma transparency are being challenged in the courts

A judge has ruled that there are likely to be no legal grounds to block the Health Research Authority’s plans for companies to register clinical trials, after the move was challenged in the courts.

The ruling means that the Health Research Authority (HRA) can push on with its requirements for all sponsors of clinical trials in active recruitment in the UK in order to gain ethical approval – a central plank of the industry’s transparency agenda.

Ruling in transparency case ‘due within days’

Sense About Science
Sense About Science outside court in Manchester for the judicial review (Twitter/Bede Constantinides)

A judge is set to rule on a controversial legal challenge to the requirement for the pharma industry to register clinical trials in active recruitment in the UK.

Clinical trials firm Richmond Pharmacology was granted permission to seek the judicial review in May.

What you need to know about the EU Clinical Trial Regulation

Published on 20/04/15 at 07:51am
EU image
European Commission HQ

 

Where did the EU Clinical Trial Regulation come from?

The EU Clinical Trial Regulation (EU-CTR) was approved in April 2014 and published in the Official Journal of the European Union on 27 May 2014. It entered into force on 16 June 2014 – but will apply no earlier than 28 May 2016.

The new legislation, once adopted, will take the form of a Regulation to ensure a greater level of harmonisation of the rules of conducting clinical trials throughout the EU.

What legislation does it replace?

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