MHRA regulatory considerations for the quality of mRNA products

Nucleic Acid Insights 2024; 1(4), 149–156

DOI: 10.18609/nai.2024.020

Published: 22 May
Expert Insight
Ka-Wai Wan, Francis Galaway

Medicinal products that use messenger RNA (mRNA) as an active substance have great potential for treating many conditions. They offer an adaptable response to changing diseases and the promise of more personalized medicines for patients. Whilst supporting innovation, the Medicines and Healthcare products Regulatory Agency (MHRA) must ensure the quality, safety, and efficacy of the product for patients. Currently, many global regulatory authorities are discussing providing specific regulatory guidance to support developers in the mRNA field. In this article, we discuss some of the key considerations for the MHRA when assessing the quality of mRNA-based medicinal products.