Medicines and Healthcare Products Regulatory Agency: Reform

Measures introduced by the MHRA include published guidance on its approach to assessing medicines applications using alternative methods, and development of an early regulatory review process, from January 2027, for relevant dossier sections that do not involve animal testing. This will help applicants understand regulatory expectations before submitting a full application. The MHRA has analysed past submissions to quantify use of alternative methods, presented this internationally, and plans to publish the findings. It is also developing systems to record future submissions. Its science campus is developing alternative methods for toxins and vaccines, while improving welfare where animal use remains necessary.