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HDA UK Media and Political Bulletin – 5 July 2021

Media Summary

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 Parliamentary Coverage

MHRA puts delivering for patients at the heart of its Delivery Plan 2021-2023
Medicines and Healthcare products Regulatory Agency, 4 July 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a new delivery plan which aims to focus on delivering meaningful outcomes for patients, protecting public health and becoming a world-leading regulator.

Priorities involves delivering the recommendations set out in the Independent Medicines and Medical Devices Safety Review.

There will be new legislation to ensure safe access to medicines and devices, including a public consultation from Q1 2021/22 and a consultation on a national scheme to replace the Falsified Medicines Directive’s (FMD) safety features regulation by Q4, 2021/22.

Additionally, the MHRA will implement a new legislative framework for medical devices by the end of Q2, 2021/22, with relevant statutory instruments laid by Q1, 2022/23.

The plan is to develop new regulatory frameworks and quickly realise the benefits of new therapies and innovative technologies such as artificial intelligence (AI), to improve outcomes for patients; and ensure the continued safety, quality and efficacy of medicines and medical devices.

Other priorities highlighted by the MHRA include scientific innovation, as well as, patient safety and risk management, a secure supply chain, and delivering the Transformation Programme to drive change and leverage international partnerships. The plan will be supported by a new committee structure, with a refreshed Board and Executive Committee.

Underpinning this delivery is the creation of a new business model that provides a financially sustainable future that will meet the increasing expectations of patients, healthcare professionals, partners, the pharmaceutical industry, government and wider industry and non-profit stakeholders alike.

The MHRA’s new delivery plan also sets out how the UK will apply the lessons learned from the pandemic and seize the opportunity of innovation after leaving the EU to make sure NHS patients are able to benefit from all medical innovations.

Written Question – House of Commons, 14 June 2021

Daniel Zeichner (Labour, Cambridge): To ask the Secretary of State for Health and Social Care, what plans he has to ensure the Medicines and Healthcare products Regulatory Agency (MHRA) adopts innovative processes to help UK patients get earlier access to regulatory-approved medicines.

Written Question – House of Commons, 14 June 2021

Daniel Zeichner (Labour, Cambridge): To ask the Secretary of State for Health and Social Care, what assessment he has made of the effectiveness of the covid-19 vaccines approval process and whether lessons from that process can be applied to support the development and approval of other innovative medicines and treatments.

Written Answer – House of Commons, 2 July 2021 

Ms Nadine Dorries (Conservative, Mid Bedfordshire): The rapid approval and delivery of clinical trials in the United Kingdom to respond to COVID-19 has made a leading contribution to the international vaccine and therapeutics effort. In March the Government set out its vision for the future of clinical research delivery to create a patient-centred, pro-innovation and digitally-enabled research environment. Implementation plans and strategies setting out how the Government and devolved administrations will begin to deliver the vision during 2021 to 2022 will be published shortly.

The Medicines and Healthcare products Regulatory Agency (MHRA) launched the Innovative Licensing and Access Pathway (ILAP) at the start of 2021, to reduce the time to market for innovative medicines. The ILAP combines the MHRA’s independence and high standards of quality, safety and efficacy, with improved efficiency and flexibility. It provides a single integrated platform between the MHRA, partners and the medicine developer, to ensure that patients receive the highest quality medicines and treatments as soon as they become available.

 

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HDA UK Media and Political Bulletin – 5 July 2021

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

See the Infographic

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