Building on its three-year corporate plan which launched last year, the Medicines and Healthcare products Regulatory Agency has now set out an ambitious new business plan for 2024/25.
The plan, which boasts a raft of key performance indicators along with a host of objectives, sets its foundations in four priorities.
They are to:
- maintain public trust via transparency and communication;
- enable access to new, safe and effective medical products;
- deliver scientific and regulatory excellence through strategic partnerships; and
- become an agency where people flourish alongside a responsive customer service culture.
Objectives
The MHRA has set out a number of ways it intends to work towards those priorities.
The first objective, for example, will be supported by the implementation of both the patient involvement and strengthened safety communications strategies.
A single, unified agency gateway will also be piloted as part of a move to streamline enquiry responses and thus improve customer satisfaction.
For the second point, the MHRA will launch a refreshed Innovative Licensing and Access Pathway while also finalising the Innovative Devices Access Pathway, with next steps set to be determined by the end of Q4.
The agency’s two new IT systems – SafetyConnect and RegulatoryConnect – also feature. Improved reporting systems in the former as well as the second release of RegulatoryConnect will both launch by the end of Q4 too.
The third part of the plan will centre around publishing the science strategy by the end of Q4 while also preparing legislation to deliver a new, risk-proportionate UK clinical trials regulatory framework.
The fourth and final priority will be achieved through a review of the recruitment and promotion processes at the agency, a new talent management plan, an annual recognition scheme, and several actions to promote a more open culture.
KPIs
The plan also sets out a number of KPIs for the agency to meet which range from delivering scientific advice to 95% of requests within 70 days of being asked, to finalising 95% of medicine licence applications within 210 days using the national route.
Completing 95% of all initial clinical trial authorisations and clinical investigations applications within the statutory timeframe is another KPI.
Responding to the launch of the new business plan, the MHRA’s CEO, Dr June Raine, said: “To take full advantage of today’s exciting developments in science and technology for the benefit of patients, we will focus on facilitating access to innovative new products while also ensuring continued access to well-established healthcare products that are the backbone of NHS healthcare.
“We will continue to invest in our talented staff by creating satisfying roles and careers, implement an exciting and robust talent management programme, promote diversity and inclusivity and continue to grow as an organisation where every individual can reach their full potential and deliver excellent performance.”
Read the plan here.
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