Developing healthcare products - MRC

Contents

How we are influencing new regulations

Following EU exit, there is an opportunity for the UK to regulate healthcare product development differently. The Medicines and Medical Devices Act 2021 paves the way for this. The details of this regulation will be in secondary legislation, which the MHRA is currently planning for.

MRC Regulatory Support Centre activities

In the MRC Regulatory Support Centre, we help ensure that the academic voice is heard by those drafting new regulations. We do this by:

  • being a member of MHRA-led working groups
  • convening stakeholder groups with representation from investigators, clinical trial units and university sponsors to provide written comments and discuss proposals with key staff at MHRA
  • hosting events for the academic community in collaboration with regulators, to facilitate wider discussion and input, furthering the discussion with a small working group to see how RSC can add value
  • responding to public consultations, convening input from relevant MRC-funded researchers.

Learn more or get involved

Email: rsc@mrc.ukri.org

Regulatory science

In the recent past new technologies have accelerated advances in fields such as use of AI in medicine, personalised healthcare and drug discovery. New technologies in healthcare (and some existing ones) are not always well catered for by current regulation, and different approaches and regulatory standards may be required to ensure that these products are safe and effective, and that they work as intended.

Regulatory science determines how best to do this. It is multidisciplinary by nature, bringing together experts in ethics, regulation, policy-making, quality management, medicine, economics, research and biotechnology.

Birmingham Health Partners Centre for Regulatory Science and Innovation (CRSI)

This centre was established in 2020 to support the development and delivery of novel therapeutics and medical devices in the UK, through advanced regulatory standards and tools. A truly multidisciplinary initiative, CRSI brings together experts in medicinal science, health policy and management, clinical trial design, medical law and patient-reported outcomes research, from across Birmingham Health Partners member organisations.

Newcastle University Centre for Regulatory Science

The Newcastle Regulatory Science Centre aims to deepen understanding of safety, effectiveness and value of medicines and devices using interdisciplinary scientific knowledge. The team works in development and translation of pharmaceutical, medical devices and health products. They carry out empirical work on safety, efficacy, quality and cost effectiveness, that they link to regulatory systems for health technology assessment, approvals and market access, clinical guidelines for medicines, vaccines devices and other new therapies.

Last updated: 24 January 2022

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