The 2019-20 Business Plan for the Medicines and Healthcare Products Regulatory Agency (MHRA) has been published, explaining the Agency’s goals for the next year.
The plan highlights some of MHRA’s successes from 2018-19, including collaboration across the Department for Health and Social Care (DHSC) and the whole of Government in planning for Brexit, implementing the Falsified Medicines Directive (FMD), and granting 19 Promising Innovative Medicines (PIM) designations, as well as four Early Access To Medicines Scheme (EAMS) opinions.
Key actions have been identified to focus the Agency on delivering the strategic objectives laid out in its Corporate Plan 2018-23:
- Protect public health and promote patient safety by ensuring the safety, efficacy and quality of medicines and healthcare products through enhanced partnerships in the UK and internationally
- Support and enhance innovation and accelerate routes to market to benefit public health and be a magnet for life sciences
- Deliver robust proactive surveillance for medicines and medical devices to achieve measurable public health benefit
- Ensure the medicines and medical devices supplied are sufficiently safe
- Be an exemplar of organisational excellence and efficiency
The Plan breaks these actions down into focussed deliverables, enabling stakeholders to track the Agency’s performance.
Notably, the Plan has been issued in the context of Brexit, and the Agency point out that there are likely to be major financial implications of leaving the EU. MHRA say:
“EU Exit and the Operational Transformation Programme are having a profound impact on the Agency’s finances. To address these financial pressures the Agency is taking the following steps:
“DHSC has committed to support the Agency in adjusting to its changing financial circumstances. This support will help to ensure that the regulator is able to maintain its expertise throughout this period of uncertainty while having to invest in contingency arrangements under various EU Exit scenarios.”