Add us as a preferred source
As part of the MHRA’s strategy commitments, regulatory frameworks will be more adaptive and responsive to innovation.
The Medicines and Healthcare products Regulatory Agency (MHRA) has set out its plans to translate cutting-edge scientific and technological innovation into better health outcomes for patients across the UK as part of its 2030 Strategy.
The MHRA has said its strategy will enable the regulator to keep pace with rapid advances in science, technology and personalised healthcare to benefit patients. The strategy also aims to position the UK as a leading place to develop, launch and use new medicines and technologies safely and effectively.
Among its commitments is a plan to create an MHRA Centre for AI and Digital Health. This will help to clarify regulatory requirements for developers of digital and AI-driven medical devices and medicines. An adaptive regulatory framework for AI medical devices will also be established to better reflect how the technology continues to develop.
As recently reported by Healthcare Today, this follows the government’s recent decision to accept all 44 recommendations made by the NHS doctor-led National Commission into the Regulation of AI in Healthcare.
Key objectives
Within the strategy, the MHRA has outlined its six key objectives, in addition to providing more details on the ambitious changes it will be making. These are to: lead real-world evidence generation and regulation; enhance access to real-world data from hospitals and genomics; recruit specialised skills and expertise and use artificial intelligence (AI) to analyse real-world data and identify potential safety issues earlier; work with the Health Data Research Service (HDRS) to use real-time surveillance to identify safety concerns sooner and collect data on investigational medicinal products.
Also listed as a key objective is improving the collection and use of medical device data, and enabling precise identification and traceability of devices throughout their lifecycle. Yellow Card reporting of adverse events with medicines will also be simplified for patients and healthcare professionals, the MHRA said.
The regulator has also outlined that it will address risks to public safety from criminal activity, including counterfeit and illegally supplied products. The MHRA will “robustly tackle” false or misleading information about medicines, vaccines and medical devices, the strategy details.
Ground-breaking developments
“We are in the midst of a period of extraordinary scientific and technological discovery, which is helping to reshape how diseases can be prevented, diagnosed and treated,” explained Lawrence Tallon, the MHRA’s chief executive.
“AI is transforming both regulated products and how organisations are run. Cell and gene therapies are offering the possibility of long-lasting or curative treatments. Precision and personalised medicines are transforming the accuracy and effectiveness of treatments. Advanced diagnostics are driving earlier intervention and better outcomes for patients,” he said.
“These ground-breaking developments challenge traditional regulatory models and require innovative approaches to evidence generation, clinical research design, manufacturing oversight and safety and surveillance,” Tallon added. “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.”
Another commitment in the strategy is to create a more flexible and risk-proportionate regulatory framework for rare disease therapies. To help with this, the UK’s genomics capability will benefit from better connection between the NHS and the MHRA to improve access to treatments, and to establish the UK as a global leader in rare disease innovation, the MHRA said. Working closely with HDRS will provide the MHRA with a comprehensive view of product safety in real-world use, it said. This will support linked data collection for investigational medicinal products, including those being assessed under the MHRA’s new Rare Diseases Therapies Regulatory Framework.
Women’s health focus
The strategy has also made a commitment to increase diversity in clinical studies. To help with this, the MHRA will launch a women’s health plan later this year to secure better outcomes for women, and to close health gaps between different ethnic groups.
“We want patients to benefit faster from the latest medicines and technologies, while maintaining the highest standards of safety,” said James Frith, the government minister for health innovation. “This strategy will help the MHRA keep pace with the latest innovations in AI, data and medicine, while strengthening its ability to crack down on illegal medicines to keep the public safe.”
By 2030, the MHRA aims to be even more patient-centred, support patients in having faster access to safe, effective treatments, and have more data connectivity and global influence.
