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UK government updates the Model Clinical Trials Agreement

New regulation aims to speed-up R&D

clinical trials

A new UK agreement that aims to speed up clinical trials and medicines R&D, whether conducted by industry or NHS research sites, has come into force.

The new version of the Model Clinical Trials Agreement (mCTA) provides a single model contract for commercial R&D to be used across all countries of the United Kingdom.

It’s the first update to the agreement since 2011 and its aim of reducing the administration burden on those conducting research has the support of industry bodies.

Sophie Gillmore, chair of the ABPI’s Clinical Research Expert Network, said: “At present, companies have to spend time preparing contracts in each of the four nations of the UK for the same study.

“The new mCTA will negate this requirement and should result in a faster and smoother set up process of commercial studies across the UK.”

According to The Association of the British Pharmaceutical Industry (ABPI), the update, which came into effect 1 March, has been warmly welcomed by the life science industry, especially across Northern Ireland, Wales and Scotland.

Ricky Verrall, head of chief scientist office of the Scottish government, said: “Delivering a single UK agreement streamlines the research environment across the whole of the UK and improves our international competitiveness.

“This collaborative approach is an important step forward and supports our ongoing commitment to create an efficient, supportive and enabling environment for industry-sponsored trials.”

Article by
Gemma Jones

2nd March 2018

From: Regulatory



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