TrialScope Atlas

TrialScope Atlas

19 May 2022

Clinical trial disclosure is a complex process driven by a constantly evolving collection of registry rules and health authority regulations.

Topic Regulation

Pink Sheet

UK BIA To Push For Post-Brexit Regulatory Agreement With EU

By Ian Schofield 27 Jan 2021

There may not be a great deal in the new UK-EU trade and cooperation deal for the life sciences industry but a new working group could act as the forum for constructive discussions on regulatory cooperation.

Topic Regulation Brexit Pharma-Brexit

In Vivo

The Times They Are A-Changin’: Opportunities In Medtech Regulation For The UK After Brexit

27 Jan 2021

The turn of the year is a chance to reflect on times past and the future, to make resolutions and look ahead to changes for the better. With Brexit in mind, this is the time to prophesize on UK medtech’s immediate future.

Topic Regulation Market Access Medtech-Brexit

Pink Sheet

EU Countries Test Offering Simultaneous Scientific Advice

By Vibha Sharma 27 Nov 2020

An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.

Topic EU Innovation Regulation

Medtech Insight

Brexit Response: Patient Safety Prioritized In Forthcoming UK MHRA Device Regulatory System

By Ashley Yeo 27 Nov 2020

Although the EU MDR and IVDR will fall outside the scope of new post-Brexit medtech regulations for Great Britain in 2021, the UK MHRA says it has the chance of developing its own world-leading regulatory regime.

Topic Medtech-Brexit Regulation Brexit

Medtech Insight

Not Too Late? German Industry Presses For EU MRA With Post-Brexit UK

By Ashley Yeo 23 Nov 2020

BVMed says the EU and the UK should set up a system of mutual recognition of medical device regulation to kick in when the UK’s EU exit transition period ends on 31 December. 

Topic Medtech-Brexit Regulation Brexit

Medtech Insight

UK Updates Medtech Industry On National Regulatory System Progress

By Ashley Yeo 23 Nov 2020

The UK will have new regulatory systems for medical devices in place for when it leaves the EU at the end of this year. The Office for Life Sciences has been fielding more questions from industry on the new structures.

Topic Medtech-Brexit Regulation Brexit

Medtech Insight

As Expected, FDA Misses Fourth Consecutive Deadline For Releasing Draft QSR

By Shawn M. Schmitt 17 Nov 2020

The US FDA’s internal deadline of October 2020 for putting out a draft of its retooled Quality System Regulation is the fourth it failed to meet. The agency has been harmonizing its decades-old QSR with ISO 13485:2016 for more than two years.

Topic Regulation

Pink Sheet

EU Pharma Strategy To Balance Innovation Incentives and Competition

By Ian Schofield 09 Oct 2020

Delegates at this week’s TOPRA conference heard the European Commission’s “holistic” vision of what it would like to achieve through its pharmaceutical strategy, including incentives for innovation, security of the supply chain, product shortages, real world evidence and big data, and the availability and affordability of medicines.

Topic EU Artificial Intelligence Regulation