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MHRA Targets World-Leading Innovation and Safety in New Plan

on Thursday, 08 July 2021.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its new three-year delivery plan, drawing on the recent successes in being the first regulator in the world to approve a COVID-19 vaccine.

It focuses on innovation, collaboration, and contributing towards scientific development - whilst all the while not compromising on safety, efficacy and quality.

The document states a bold objective: "Our purpose is clear: to protect and improve patient health by enabling the earliest access to, and high-quality supply of, safe, effective and innovative medical products through proportionate, data-driven assessment of risks and benefits.

We aspire to be a leading global example of delivering excellence in public health and patient safety, enabled through regulation and at the forefront of innovation. Delivering our vision relies on our ability to act as one agency and to relentlessly pursue the delivery of meaningful outcomes for the patients we serve.

This means drawing together our scientific rigour and regulatory expertise to address the challenges faced by the life sciences sector and health service; how best to develop new regulatory frameworks and quickly realise the benefits that new therapies, artificial intelligence and innovative healthcare products can bring to patients, while still ensuring the right levels of safety, quality and efficacy. It also means more systematic engagement with patients and putting patient outcomes at the heart of what we do.

Following our departure from the European regulatory system, we will seize the opportunities to evolve our regulatory framework and keep pace with fast-moving life science developments, from novel personalised medicines to software and artificial intelligence, whilst ensuring our regulation provides the utmost protection of patients. We continue to play a pivotal role in the health and social care system and a leading role internationally. We are committed to delivering our objectives in collaboration with others within and beyond the UK."

The MHRA has set out the following six themes:

  • scientific innovation
  • healthcare access
  • patient safety
  • dynamic organisation
  • collaborative partnerships
  • financial sustainability

The plan talks about how the MHRA has demonstrated in the last 18 months how it has worked closely with partners in the UK and internationally, to support the NHS with technologies and therapies it has needed, working quickly and thoroughly to facilitate and approve clinical trials which have generated a sound evidence base. Its rolling reviews of evidence enabled rapid approval of licences for products, whilst maintaining high standards of safety, efficacy and quality.

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Key Details of the Plan

Here are some of the key details:

  • Overhaul of the clinical trials system, including changing legislation to make the conduct of trials generating real-world data easier and finalising and promoting the Innovative Licensing and Access Pathway. The MHRA wants to see a more pragmatic approach to UK clinical trials.
  • New legislation to ensure safe access to innovative medicines and devices, and a consultation on a national scheme to replace the EU's Falsified Medicines Directive’s safety features regulation.
  • An integrated UK regulatory pathway for products that combine medicinal products and medical devices.
  • Work closely with the Northern Ireland Executive to ensure effective regulation and timely access to life-saving medicines and medical devices.
  • A more responsive safety surveillance and risk management system.
  • Continued collaboration with EU regulators, through the establishment of the Medicinal Products Working Group, which was established under the Trade and Cooperation Agreement. Meanwhile, establishing collaborations with regulators in other countries. In addition, establishing greater international regulatory collaboration and alignment with the Access Consortium so patients benefit from timely access to high quality, safe and effective medicines.

Read the full MHRA Delivery Plan.

Leading the Way

In the COVID-19 pandemic, the UK led the world in so many fronts - from the collaborations between the leading academia, business and NHS care system with innovation, use of data, data sequencing, and through to an innovative regulator. The MHRA certainly played its part and has continued where it left off - wanting to lead the world with enhancing the achievements of innovation and collaboration developed over the last few months beyond the pandemic and to be a beacon to the world.

At the PING Conference 2021 to be held this year, in collaboration with IQVIA we will be looking at areas where the UK is taking a lead in life sciences as a result of the pandemic response, and we will be covering these areas further with some leading speakers, including from the MHRA. Find out more about the event.

If you would be interested in hearing more about these issues and being invited to attend the PING Conference, please contact Paul Gershlick in our Pharmaceuticals & Life Sciences team on 07795 570072, or complete the form below.

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