Regulatory Requirements for Nanotechnology-Based RNA Vaccines and Therapeutics, a quick-start guide

The Intracellular Drug Delivery Centre (IDDC) is a Centre of Excellence led by CPI in partnership with Medicines

Part of the Intracellular Drug Delivery Centre’s (IDDC) mission is to ensure that we are providing those in the ecosystem with the support they need to enable the successful translation of intracellular drug delivery technologies from research to commercialisation, creating the right environment for this sector to anchor and grow in the UK.

Sector engagement has provided clear feedback that those developing new therapies and vaccines with a delivery vehicle were unclear on the regulatory and quality data requirements and the pathways to product registration. The sector would welcome improved guidance or regulatory science support for novel delivery technologies.

The Pathway to Product Registration

Navigating the complex regulatory pathways for nanomedicines can be a significant challenge for innovators and this has been highlighted by the nanomedicine community. The challenges were identified by the Vaccine taskforce mandated LNP and ICD Taskforce, which surveyed UK stakeholders between July 2020 – August 2021, these were confirmed in the surveys carried out as part of the MDC and CPI report “Shaping the UK into an epicentre for complex medicines,” and also highlighted in the regulatory session at the NanoMed Europe conference (NME23), which brought together key stakeholders from the European and UK ecosystem in June 2023.

IDDC aims to support innovators progress towards the clinic. Drawing on sector-specific expertise within the Medicines & Healthcare products Regulatory Agency (MHRA), we have developed a plan for creating clearer pathways to product registration. In essence, through provision of this guide which includes a decision tree for a “novel” medicinal product, which will help innovators navigate the relevant guidance available, to understand which guidance documents are relevant and how to access support for bespoke interpretation of the guidance.

Access the guide here.