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.
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.
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.
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.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on software (including artificial intelligence [AI]) regulated as medical devices.
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.
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.
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?
The European Medicines Agency (EMA) has published its key recommendations for marketing authorisations in 2022 in ‘Human Medicines Highlights 2022’.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has extended the designation of UL International UK Ltd as an Approved Body.
