The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has devised a new strategy to better harness advancements in personalised healthcare and technology, facilitating improved health access for patients.
Through the debut of its ‘2030 Strategy’, the UK regulator has committed to slashing the initial Phase I qualifying assessment target to 14 days, while cutting the time to its scientific advice service for drug and medical device developers from 90 to 45 days, and expediting decision-making on generic and biosimilar products. The regulator also plans to develop an artificial intelligence (AI)-enabled clinical trial protocol checker, which will help sponsors to create high-quality applications more rapidly.
On top of these efforts, the MHRA is looking to support early-stage British life sciences companies by creating a targeted voucher scheme, which it hopes will lower regulatory barriers and encourage innovation in the space. The agency is also placing a keen focus on making rare disease regulation more flexible and risk-proportionate, while facilitating the shift away from animal models to potentially more human-centric new approach methodologies (NAMs) in preclinical testing.
To enhance its approach to patients, the MHRA laid out further plans to bolster diversity in British clinical trials and refresh its approach to public and patient engagement. The data gap between ethnicities, sexes and other protected characteristics remains a significant issue, with underrepresentation in trials leading to inequitable outcomes in health systems. The agency has also taken a renewed commitment to women’s health, planning to debut its Women’s Health Plan later this year.
In addition, the 2030 plan places a key focus on real-world data (RWD), meaning the UK regulator has committed to bolster access to RWD on drugs and medical devices. To make best use of this data, the MHRA will hire AI-proficient data analysis experts who will help to more rapidly identify safety concerns in real-time.
To expand on this, the regulator will also tighten its Yellow Card adverse event reporting system for both drugs and medical devices – working to make it simpler and quicker to use for patients and healthcare providers alike.
British life sciences players back the 2030 Strategy
According to the MHRA’s chief executive, Lawrence Tallon, recent developments in the rapidly evolving life sciences space have been challenging traditional regulatory models, meaning “innovative approaches to evidence generation, clinical research design, manufacturing oversight and safety and surveillance” are necessary.
“Our 2030 Strategy sets out how, working with our partners across health and life sciences, we will translate scientific and technological innovation into better health outcomes for people across all four nations of the UK,” Tallon commented.
Meanwhile, UK health innovation minister, James Frith, added that the new strategy will help the MHRA to keep pace with the latest developments in AI, data and medicines, while putting patients “at the heart of regulation” and allowing the regulator to crack down on illegal medicines.
Richard Torbett, CEO of the Association of the British Pharmaceutical Industry (ABPI), also expressed his positive sentiments towards the 2030 Strategy, noting it was “clear on speed, standards, and how performance will be measured, with firm service guarantees.”
The MHRA’s debuts this strategy as the UK government looks to enhance the nation’s competitiveness on the global life sciences stage – introducing policies like the Life Sciences Sector Plan to make Britain an attractive place for companies in the sector to grow.
However, experts previously highlighted the need to improve the UK’s clinical trial setup times, financing landscape and standing as a commercial market to see marked change in the coming years.
