In a new report, the Association of the British Pharmaceutical Industry recommends how the Healthcare Products Regulatory Agency can rebuild the UK’s reputation in regulatory science.
The Association of the British Pharmaceutical Industry (ABPI) has called on Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) to rebuild the country’s approach towards medicines regulation.
A new report from the organisation that represents companies that research and develop medicines and vaccines explores the role of regulation in driving innovation and early access, supporting patient trust, and attracting investment into the UK.
“The MHRA has long been regarded as a well-respected, global leader in medicines regulation, underpinned by solid expertise and innovative approaches. However, events in recent years have tested its resilience and capabilities,” says Richard Torbett, chief executive of the ABPI.
The report sets out 12 recommendations to rebuild the UK’s reputation in regulatory science, and the development and licensing of medicines.
These recommendations are based on three themes.
First is that of enhanced communications, transparency and accountability. Pharmaceutical companies depend on finding regulatory and technical information quickly and easily and require access to performance metrics that inform the planning of product launches, it says. They also need to have dedicated points of contact that provide relevant and timely information, particularly for scientific and technical advice and procedural queries, facilitated via stronger internal and external accountability mechanisms.
Second, the report calls on regulatory authorities to provide expert opinion and consistency in approach, keeping up to date with evolving technological advances. “A well-resourced regulatory authority should provide predictable and reliable services and ensure that the right capacity exists to focus delivery on key regulatory statutory functions,” it says.
Finally, the report points out that growth in clinical trial activity depends on timely approvals and acceptability of innovative approaches. Regulatory reliance offers better use of resources and potential leadership in particular areas with horizontal agreements and positioning of the MHRA as a reference regulator.
“A re-energised regulatory system in the UK would lead to faster patient access to new innovative medicines and a healthier population, as well as increased inward investment from Life Science companies,” says Rippon Ubhi, country lead and general manager for speciality care at Sanofi UK & Ireland.
