Blog archive

UK medical devices regulator, the MHRA, is planning a 12-month extension to its planned reforms of the regulatory system, and a new approach to provide effective and proportionate regulation for the growing software and AI medical device sectors. What can business expect?

A patent application relating to an app to support patient compliance with a medicine dosing regime did not meet the European Patent Office requirements for protection.

We look at a new visa route for fast and high growth companies seeking to hire skilled people from around the world.

We review progress on the UK Government consultation on the regulation of medical devices, and look at the shape and timing of forthcoming reforms.

We look at some recent examples of enforcement of advertising rules in the life sciences sector in the context of online promotional activity.

The ABPI is proposing a new set of principles to improve public trust and transparency around the use of health data.

We look at the Good Machine Learning Practice guidance for medical devices drawn up jointly by regulators in the US, Canada and the UK.

Pharmaceutical research and development activity involves substantial investment and ingenuity. Should this be taken for granted when assessing the inventiveness of pharma patents?

We take a look at the ABPI's Vision Paper on UK medicines regulatory policy and global influence in a post-pandemic world.

The EU is now well on its way to completing the roll out of its new regulatory system for medical devices. The Medical Devices Regulation is now in force, and the In Vitro Diagnostics Regulation will follow next May...

It has been a while, but the EU Clinical Trials Information System (CTIS) is set to go live on 31 January 2022. This means that the system set up in 2014 under the Clinical Trials Regulation will finally come into effect.