The Medicines and Healthcare products Regulatory Agency (MHRA) has published its business plan for 2017/2018. This plan sets out how the MHRA proposes to meet its objectives to enhance and improve public health via the effective regulation of medicines and medical devices. Unsurprisingly, a key focus is on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following the UK’s exit from the EU.
MHRA is seeking to develop an international strategy and enhanced national strategy for collaboration and engagement with key partners and stakeholders to facilitate better regulation and innovation. Clearly, the agency will be focused on establishing a consensus around a proposed model for future regulation of medicines and medical devices in the UK, post-Brexit. The MHRA says that this model will protect public health, facilitate innovation and minimise burden on industry.
There is much work to do for the MHRA to understand its future relationship and level of engagement with EU regulatory agencies, including the potential for ongoing co-operation in EU regulatory procedures. The MHRA will seek to continue with participation in EU systems as much as possible, particularly to support earlier access to innovative products, for example through the Priority Medicines scheme (PRIME) and adaptive pathways.
On the devices front, the UK is expected to align with the new EU regulations for medical devices and IVDs. The plan contains proposals to introduce fees for device manufacturer vigilance. This change will require primary legislation so therefore take some time to implement.
Brexit is not the only challenge the MHRA will face; the plan also cites rapid advances in medicines and medical technologies and challenges faced by partner organisations across the health sector, plus the need for financial prudence.
To access the MHRA Business Plan 2017-18, click here.