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Medtech Insight: 世界の医療機器・医療技術の最新情報

Interview: ‘More Forward Thinking’ Needed For UK IVD Industry As Brexit Looms

Incoming head of diagnostic regulation at the UK ABHI Steve Lee makes a plea for more detailed MHRA guidance around product registration requirements for the post-EU national market.

Topic Medtech-Brexit Regulation

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Brexit: New Rules Will Hit Parallel Trade From UK to EU

From next year, owners of trademarks and other rights in the European Economic Area will be able to prevent the parallel export of medicines from the UK to the EEA. But those owning similar rights in the UK will not be able to stop parallel imports from EEA countries. 

Topic EU Pharma-Brexit Brexit

Medtech Insight: 世界の医療機器・医療技術の最新情報

50 Days To Brexit – And No Extension, Govt Warns UK Medtechs

High level EU-UK negotiations have yet to deliver a free trade deal. Meanwhile, the MHRA has issued more guidance for medtechs accessing the UK market in 2021.

Topic EU Medtech-Brexit Brexit

Medtech Insight: 世界の医療機器・医療技術の最新情報

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

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: 世界の医療機器・医療技術の最新情報

UK Updates Medtech Industry On National Regulatory System Progress

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: 世界の医療機器・医療技術の最新情報

The Politics And The Practice Of UK Standalone Devices Regulation

Taylor Wessing partner Alison Dennis and MHRA devices regulatory policy manager Gavia Taan provide updates on the UK’s device regulatory plans after the Brexit transition period ends.

Topic Medtech-Brexit Regulation brexit

Medtech Insight: 世界の医療機器・医療技術の最新情報

UK Updates Medtech Industry On National Regulatory System Progress

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

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Brexit Issues Lead NICE To Delay Methods Review

England’s health technology appraisal body, NICE, and the UK medicines regulator, the MHRA, are working together to align their process timelines so that access to medicines is “maintained and enhanced.”

Topic brexit Pharma-Brexit EU

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Brexit: UK Joining US-Led Project Orbis To Speed Cancer Drug Approvals

Joining the international regulatory collaboration could become a key route for the UK to remain an early and priority market for global launches after the end of the Brexit transition period, says the industry group, BIA.

Topic Pharma-Brexit brexit

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