Highlights from the BIA Future of UK Regulation Conference 2023

This is the first of four blogs reporting on the BIA’s sell-out conference, ‘The Future of UK Regulation: Driving innovation in the life sciences’. Here is an overview of measures taken by the MHRA to shape itself as a world-class, independent sovereign regulator, and some key takeaways from the three sessions of the conference. An in-depth look at each of these sessions will be published in the coming weeks.

The UK is entering a new era in medicine regulation as the Medicines and Healthcare products Regulatory Agency (MHRA) supports fast and effective clinical trial turn-around and delivery of the UK’s Life Sciences Vision, and new legislation is developed to guide its future as an independent sovereign regulator.

The vision is to take advantage of the regulatory flexibility that comes from no longer being part of the European Medicines Regulatory Network, to improve access to medicines for patients and to be a driver for innovation in the UK and beyond.

Among the challenges is the dramatic fall in the number of commercial clinical trials in the UK and capacity issues that led to a huge backlog of clinical trial applications awaiting approval over the summer.

Meanwhile, the new international recognition procedure for granting marketing authorisations is intended to speed up approvals, but also raises questions over when to use this new route and when to use the national marketing authorisation procedure.

Added to this, is the opportunity that arises from the application of novel technologies, most notably artificial intelligence, to improve the regulatory system and optimise the route from initial discovery to marketing approval, patient access and life cycle management of medicines and devices.

 “We meet as a community that has faced a challenging 2023,” said Steve Bates OBE, Chief Executive of the BIA, opening the conference. “It’s important we talk about how we get UK clinical trials back on track and ensure the regulatory system supports innovation. The BIA is committed to working with the MHRA and to making the case for proportionate, sensible regulation,” he said.

This was reflected by Dr June Raine DBE, Chief Executive of MHRA, in a keynote address that set out how the MHRA has been restructured into an integrated agency with multidisciplinary teams that can support drug development from design to delivery.

The MHRA now aims to be “in full delivery mode” while at the same time iterating new ways of working and delivering even more agile services, Dr Raine told the conference. There will be a constant process of reviewing whether services are optimal and risk proportionate. “All of this will be on the bedrock of regulatory science to support benefit-risk decision making,” she said.

“I hope I’ve shown in this presentation that the MHRA has changed from being a watchdog to an enabler,” Dr Raine concluded.

Getting UK clinical trials back on track

One of the most critical issues facing the MHRA in the overhaul of how it regulates clinical trials and supports the UK to be one of the best countries in the world to conduct clinical research, was a dramatic fall in the number of commercial trials being run here.

“I think everyone in this room can understand and believe that having an effective and efficient clinical trial system from front to back is key in delivering medicines to patients and in terms of having a healthy life sciences industry,” said Tim Stonehouse, Vice President International Regulatory Strategy, Vertex and Chair, BIA Regulatory Affairs Advisory Committee.

Front to back must encompass everything from scientific advice to the completion of a study, as set out in the review of commercial clinical trials carried out by Lord James O’Shaughnessy.

More than two years before the O’Shaughnessy review, the Future of Clinical Research Delivery provided a vision for a more patient-centred, pro-innovation and digitally enabled clinical research environment that would build on the successes and the lessons of COVID-19. This gave a mandate to accelerate implementation.

Clinical trials application assessment

The MHRA has taken a cross-agency approach and introduced new ways of working to address what were clearly some significant shortcomings in its assessment process. As a result, performance has improved and a backlog of almost 1,000 applications was cleared between July and September. Since 1 September 2023, all applications received are being assessed within the statutory timeframes.

Standardising practice

While the main regulatory function of the Health Research Authority (HRA) is to provide research ethics committees review, it has a second function, which is to coordinate and standardise regulatory practice for research across the UK. That has given it a central role in underpinning the programme of work to implement a whole system approach.

International Recognition Procedure

In one of the most notable moves made since becoming a sovereign regulator, the MHRA is creating a new international recognition framework via which it will grant UK marketing authorisations to medicines approved by other trusted regulators.

The International Recognition Procedure will come into effect in January 2024, replacing the European Commission Decision Reliance Procedure that was brought in to fill the regulatory gap after the UK left the EU in 2021, to ensure patients were not denied access to new, innovative medicines because of separate authorisation from the MHRA.

NICE’s response

Marketing approval does not equal market access. As the gatekeeper, NICE is also thinking about how it needs to change its processes to ensure that the MHRA’s new regulatory flexibility and the introduction of the International Recognition route will speed up patient access to innovative products.

International lessons

Swissmedic has operated as a sovereign regulator since it was established in 2002, giving it significant experience of treading the line between relying on the assessments of trusted counterparts and carrying out the most complex reviews of newest technologies itself to maintain and advance its in-house expertise.

Regulation of novel technologies

The regulatory response to COVID-19 demonstrated the speed and agility with which the UK system can act. While it is unrealistic to think it can always operate at pandemic intensity, the experience points the way to how the UK can build on its new regulatory flexibility and expertise in regulatory science to bring novel technologies to market.

Emerging technologies – opportunity and challenge

It is now possible to use Deepmind’s Alphafold AI system to predict the 3D structure of a protein from its amino acid sequence and design drug hits against pockets in these structures, in silico. AI can now be used across discovery and clinical development.

There is a risk-benefit balance to be struck between encouraging innovation and providing access to emerging technologies, whilst ensuring patient safety.

For more information, please contact Dr Christiane Abouzeid:

Dr Christiane Abouzeid

Dr Christiane Abouzeid

Head of Regulatory Affairs




More news and updates 

The UK's genomics sector: Poised for continued growth and impact

Genomics has become an integral part of the UK's healthcare system, revolutionising patient care and driving innovation within both small and medium-sized enterprises (SMEs) and large pharmaceutical companies. Our new report, Genomics nation 2023, highlights the profound impact of genomics on the UK's life sciences sector and public health system.

CEO Update - 4 December 2023

UK Biobank is a British success story that puts us at the heart of a key global technology of this century. Last week, UK Biobank published the world’s largest collection of full human genomes. Set up 20 years ago, the charity UK Biobank recruited half a million altruistic volunteers to create the world’s most comprehensive source of health data.

bioProcessUK 2023: Honouring excellence, unveiling future leaders 

In a symphony of innovation and camaraderie, the 20th anniversary bioProcessUK conference swept through Brighton, creating an unforgettable experience for the life sciences and biotech community.

CEO Update - 27 November 2023

Last week felt like an important milestone for the UK life science sector. As I sat in the Life Science Council in No 10 Downing Street with new Government Ministers, leaders of public institutions like the MHRA and global CEOs, I reflected that no other country in the world is putting together a working collaborative life science group like this.

bioProcessUK: The role of candidate screening and feasibility studies

Ian Goodwin, Director of CMC Program Design in Advanced Therapies (covering Cell and Gene Therapy services) at FUJIFILM Diosynth Biotechnologies explores the benefits of candidate and feasibility studies to AAV production.

Autumn Statement 2023 analysis

The Chancellor has delivered a comprehensive package of investment and support for the UK life sciences industry in his Autumn Statement. In this blog, Dr Martin Turner, Head of Policy and Public Affairs at BIA shares his reflections on key announcements.

Member spotlight: meet the Bio-Based and Biodegradable Industries Association

The Bio-Based and Biodegradable Industries Association (BBIA) and The BioIndustry Association (BIA) enter a mutual membership agreement to strengthen collaboration and support each other's work and member communities.

Bioprocessing: Unraveling the future by examining the past

Over the past two decades, the landscape of biopharmaceuticals in the UK has undergone a significant transformation.

CEO Update - 20 November 2023

London Life Sciences Week last week had an amazing buzz. I think there were more Americans in life science over for one week than I’ve ever experienced – centred on the Jefferies Healthcare Conference. At the same time, London was also full of Europeans at events like the Scrip Awards, where Jeremy Levin received the Lifetime Achievement Award and gave an impactful speech. The connectivity was immense - with a massive range of events that were really vibrant, diverse and inclusive.

London Life Sciences Week: connecting the global biotech community

London Life Sciences Week united the global biotech community for a dynamic week of networking and dealmaking. The BIA representatives were out and about throughout the week, networking with members and stakeholders. In this blog, Steve Bates OBE, CEO of BioIndustry Association, summarises insights based on the BIA team's first-hand experience.


More within