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Medtech Insight
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
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
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
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
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
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
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
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
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
Pink Sheet
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
Pink Sheet
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
Pink Sheet
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.
Medtech Insight
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
Pink Sheet
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
Pink Sheet
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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24 Nov 2020
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24 Nov 2020
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24 Nov 2020
Scrip
24 Nov 2020
Generics Bulletin
24 Nov 2020
Medtech Insight
24 Nov 2020
HBW Insight
24 Nov 2020
Scrip
23 Nov 2020
Pink Sheet
23 Nov 2020
Generics Bulletin
23 Nov 2020
In Vivo
23 Nov 2020
Pink Sheet
23 Nov 2020
HBW Insight
23 Nov 2020
In Vivo
23 Nov 2020
Scrip
23 Nov 2020
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