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MHRA announces international partnerships to accelerate medicines approvals

MHRA announces international partnerships to accelerate medicines approvals

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new international framework that will help bring new medicines to patients faster.

8 Jun 2023
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UK’s ‘Pro-innovation Regulation of Technologies Review – Life Sciences’ report outlines regulatory opportunities to speed market access

UK’s ‘Pro-innovation Regulation of Technologies Review – Life Sciences’ report outlines regulatory opportunities to speed market access

The ‘Pro-innovation Regulation of Technologies Review – Life Sciences’, published at the end of May 2023, highlights areas where improvements can be made to the UK’s regulatory environment to further enable innovation and a thriving life sciences sector. It presents ambitious ideas on developing innovation pathways and ways to support and retain talent in the regulatory organisations to ensure speed to market for new products.

7 Jun 2023
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EMA annual report reviews actions in 2022

EMA annual report reviews actions in 2022

The European Medicines Agency (EMA) has published its annual report for 2022, highlighting its challenges and successes in a year that saw it face ongoing and new public health emergencies.

24 May 2023
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Will ABPI’s ambitious VPAG plans succeed VPAS?

Will ABPI’s ambitious VPAG plans succeed VPAS?

Discussions are beginning on the next iteration of the UK’s voluntary scheme for branded medicines, pricing and access (VPAS) and the Association of the British Pharmaceutical Industry (ABPI) has set out its stall to government. It has published a four-point proposal for a Voluntary Scheme for Pricing, Access and Growth (VPAG), designed to reignite competitiveness and boost innovation in the life sciences sector, thereby improving health outcomes and the wider economy.

15 May 2023
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MHRA publishes guidance on software and AI as a medical device

MHRA publishes guidance on software and AI as a medical device

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on software (including artificial intelligence [AI]) regulated as medical devices.

18 Apr 2023
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EFPIA Director General calls for action on pharma legislation

EFPIA Director General calls for action on pharma legislation

The head of the European Federation of Pharmaceutical Industries and Associations (EFPIA), Nathalie Moll, has outlined two urgent actions that European pharma needs as the announcement of the EU’s pharma strategy has been postponed again by the European Commission.

11 Apr 2023
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UK government responds to consultation on clinical trial legislation

UK government responds to consultation on clinical trial legislation

In order to strengthen the UK’s regulatory environment for clinical trials in an increasingly competitive global market, the government plans to prioritise safety and efficacy, while minimising regulatory burdens on trial sponsors.

6 Apr 2023
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Windsor Framework returns NI medicines control to UK

Windsor Framework returns NI medicines control to UK

The recently announced Windsor Framework seeks to restore Northern Ireland’s position as part of the UK and thereby undo the political, economic and societal challenges brought about by two years under the Northern Ireland Protocol. As over 1,700 pages of EU law will no longer apply in the region, what will be the situation for medicines supply once the deal goes through, and how will greater cooperation with the EU impact research and innovation under Horizon Europe?

20 Mar 2023
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EMA publishes overview of medicines recommended in 2022

EMA publishes overview of medicines recommended in 2022

The European Medicines Agency (EMA) has published its key recommendations for marketing authorisations in 2022 in ‘Human Medicines Highlights 2022’.

21 Feb 2023
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MHRA ramps up assessment capacity for in-vitro diagnostic devices

MHRA ramps up assessment capacity for in-vitro diagnostic devices

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has extended the designation of UL International UK Ltd as an Approved Body.

30 Jan 2023
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