The UK’s Intracellular Drug Delivery Centre (IDDC) has created a new regulatory roadmap for innovators developing RNA therapeutics and vaccines – a new class of medicines based on ribonucleic acid. With input from the Medicines and Healthcare products Regulatory Agency (MHRA), the go-to guide aims to simplify the journey from research to commercialisation.
The IDDC has delivered the resource in response to engagement with the sector, making the pathway to product registration clearer.
The roadmap aims to help innovators developing new therapies and vaccines understand regulatory guidance, how to identify the most relevant information to them and how to access support for bespoke interpretation of the guidance.
Drawing on sector-specific expertise within the MHRA, a decision tree on how to navigate nanotechnology-based products for medical applications has been incorporated. The guide helps innovators define their products and points to the relevant ICH guidance documents.
RNA therapeutics are one example of ‘complex medicines’, which can be challenging to characterise as they often consist of different but closely related structures rather than a single well-defined chemical entity. It can also be difficult to identify specific characteristics of the active moiety (the part of the molecule responsible for the action of the medicine) or its delivery system that might impact therapeutic performance.
This presents challenges for innovators and regulatory authorities alike, with established regulatory frameworks having to evolve to accommodate ever-diversifying complex medicines.
Sarah Brockbank, Strategy Leader – Complex Medicines at Medicines Discovery Catapult, said:
“Part of the IDDC’s mission is to provide drug discovery innovators with the support they need to enable the successful translation of intracellular drug delivery technologies, from research to commercialisation. This guide has been developed in response to a call from our community for improved guidance and regulatory science support for novel delivery technologies. We hope innovators developing the next generation of complex medicines find it a useful resource to help accelerate their progress.”
Dr Juliana Haggerty, Head of Centre of Excellence – LNP & Intracellular Drug Delivery Centre, CPI, said:
“The field of RNA therapeutics and vaccines is fast moving and holds huge promise, and we’re delighted that the IDDC has been able to work with the MHRA to produce this guide. We believe it will be an invaluable resource for innovators, helping them to navigate regulatory pathways and accelerate their route to market.”
Julian Beach, Interim Executive Director Healthcare Quality and Access, Medicines and Healthcare products Regulatory Agency, said:
“With this decision tree and other publications, the MHRA is supporting interpretation of guidance and requirements to bring innovative medicines rapidly forward for the benefit of patients, enabling safe, effective and quality medicinal products to be supplied.
“In turn, this will be supported with advice and other offerings, such as ILAP, where we can make a real difference with all partners involved.”
IDDC is a Centre of Excellence led by CPI in partnership with Medicines Discovery Catapult and three leading universities: the University of Strathclyde, the University of Liverpool and Imperial College London.
Funded by Innovate UK’s Transforming Medicines Manufacturing programme, with a grant of £10 million over three years, the Centre provides a single point of entry for drug discovery innovators to access new capabilities in intracellular drug delivery.
