MHRA’s 2024/25 business plan offers exciting opportunities for innovative therapies
The MHRA’s 2024/25 business plan offers exciting opportunities for pharmaceutical companies looking to bring innovative medicines and devices to market. Key priorities include maintaining public trust, improving regulatory excellence through strategic partnerships, and enhancing service delivery with new IT systems like SafetyConnect and RegulatoryConnect. The plan also supports UK life sciences growth, pandemic preparedness and sustainability efforts in healthcare product regulation.
Key Updates in the MHRA Plan
Fast-Track Approvals for Innovative Technologies
The MHRA aims to provide individual timeframes for applicants, with an enhanced Innovative Licensing and Access Pathway (ILAP) prioritising faster review times for the latest cutting-edge medicines. This is crucial for companies developing pioneering healthcare interventions, as they can navigate the regulatory process more efficiently, expediting time-to-market. Companies must ensure all data submission and regulatory pathways are optimally aligned with ILAP requirements.Advanced Regulatory IT Systems
The introduction of SafetyConnect and RegulatoryConnect signals the MHRA's commitment to improving communication and collaboration. SafetyConnect will ensure the MHRA can respond effectively to new safety signals throughout the product life cycle, while RegulatoryConnect will modernise existing management systems and support state-of-the-art interactions with stakeholders. For companies, these systems reduce administrative burden, allowing them to focus on innovation.Focus on Digital Health and Medical Devices
The MHRA is increasing its support for medical devices and digital health technologies while finalising the Innovative Devices Access Pathway (IDAP) pilot phase. With improved regulatory frameworks and faster market access pathways for connected devices and diagnostics, companies developing device-drug combinations or AI-powered diagnostics will benefit. This move signals that digital tools and devices will increasingly play a role in the future of healthcare.Public Trust and Scientific/Regulatory Excellence
As the MHRA works to enhance public trust, it has committed to clearing any remaining regulatory backlogs and to improving service delivery transparency, which will benefit companies by enabling better predictability and faster responses to regulatory submissions. A network of Centres of Excellence in Regulatory Science and innovation will be established to ensure that regulatory decisions reflect the best available science.
Implications for Pharmaceutical Companies
Looking Ahead: Future Developments
Post-Brexit Collaborations: Pharmaceutical companies should monitor how the MHRA continues to collaborate with international regulatory bodies like the EMA and FDA. The Access Consortium, which comprises the MHRA and the national regulatory authorities of Australia, Canada, Singapore and Switzerland, has also developed a strategic plan for 2021-2024 to enhance efficiency and optimise synergies. Changes in mutual recognition agreements may affect submission strategies for companies targeting multiple markets.
NICE Methodology Updates: NICE’s evolving appraisal processes for advanced therapies and rare disease treatments are expected to impact market access timelines. Pharmaceutical companies should ensure their products are not only clinically effective but also provide clear cost-effectiveness and patient outcomes data.
The MHRA’s 2024/25 plan presents an open door for innovation, but success in navigating this landscape will require meticulous planning, strategic use of new regulatory tools, and collaboration with market access experts.
By staying informed on regulatory shifts and focusing on early engagement with agencies like MHRA and NICE, we can help our clients seize these opportunities and accelerate access to transformative treatments for patients in the UK and beyond.
Written by Farhaan Jamadar
Decisive Dialogue 29th October 2024
If you’re interested in our hands-on experience guiding clients through ILAP or need support with HTA and regulatory submissions, connect with us at enquiries@decisiveconsulting.co.uk