Posted by In response to the letter (31 January) from Mark Samuels, chief executive of the British Generic Manufacturers Association (BGMA), we want to assure readers that supporting the health system to tackle shortages is a priority for the Medicines and Healthcare Products Regulatory Agency (MHRA) and that we work with many partners, including the BGMA, to do so.
We are taking significant steps to assess applications for generic and established medicines in the shortest time possible. We will always prioritise applications according to public health need.
Approvals such as that for the diabetes and weight management treatment Mounjaro KwikPen, which we were the first major regulator to licence, demonstrate our commitment to this.
We are working with industry to reduce timelines and to develop processes that will result in significantly improved response times while protecting patient safety. We will continue to work with the Department of Health and Social Care, as the lead for medicines supply, and others across the health system, including the NHS, to assess potential shortages and provide support.
As an effective regulator, we are committed to the highest of standards of performance and delivering the right outcomes for patients and public health.
Dr June Raine
Chief executive, MHRA