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Medtech Insight

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

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Pink Sheet

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

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Medtech Insight

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

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Medtech Insight

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

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Medtech Insight

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

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Medtech Insight

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

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Medtech Insight

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

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Pink Sheet

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

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Pink Sheet

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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Pink Sheet

UK Firms Face Thousands Of Variations To Update Safety Information

With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.

Topic Pharma-Brexit Safety Brexit

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Pink Sheet

Act Quickly On Converted EU Product Approvals GB Firms Urged

The UK medicines regulator has written to pharmaceutical companies outlining the actions they need to take regarding products with a centralized EU approval that will be converted to Great Britain marketing authorizations next year.

Topic Pharma-Brexit Brexit Approvals

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Pink Sheet

US Drug Pricing Reform Post-Election: Scenarios To Consider And Lessons Learned

Regardless of the outcomes of the US elections, drug pricing is likely to take a back seat to COVID as policy focus. But the pandemic does offer pharma an opportunity for partnerships with payers on health outcomes. Commonwealth Fund’s Liz Fowler, South Capitol’s John O’Brien and ICER’s Steve Pearson discuss where drug pricing stands in public opinion, whether policies embraced by President Trump will have staying power, and the conditions needed in the policy environment for major change.

Topic US Election 2020 Policy & Regulation Drug Pricing

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Medtech Insight

US Election 2020: Industry Loses Three Favored Incumbents In Battle For Senate Control

A few of the US Senate candidates favored and given tens of thousands of dollars by industry have lost their battles for re-election

Topic US Election 2020 Legislation

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Pink Sheet

Biden Administration May Push Rx Pricing To Back Burner With Senate That Stays Pharma Friendly

A Biden Administration with near-term priorities other than drug pricing and a Republican-controlled Senate dedicated to blocking any legislation that would enact government price controls is a relatively positive outcome for industry

Topic US Election 2020 Drug Pricing

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Pink Sheet

China-US Relationship Hinges On Changing Internal, External Forces

Given the ongoing election challenges in the US, China has yet to officially congratulate Joe Biden as the next US president, although many world leaders are already hailing a reset in US foreign policy. Many are wondering if this and other moves indicate a quiet internal shift for China's high tech and life sciences sectors, just days after Beijing concluded a high-level plenary meeting outlining its priorities for the next five years.

Topic US Election 2020 China

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