Last month, the EMA held a public stakeholder meeting to discuss regulatory and scientific considerations for RNA-based medicines. The sessions covered introductory views, quality, nonclinical and clinical aspects for these novel therapeutics. This first analysis discusses the potential need for identification of a new pharmaceutical class for these molecular entities, which don’t fit neatly into the existing chemical or biologic categories.
Background on RNA-based medicines
RNA-based medicines can be divided into two large categories: messenger ribonucleic acid (mRNA) and non-coding RNA-based medicines. The mRNA category would include mRNA used in therapeutics, mRNA-based vaccines and mRNA-based cell therapies.
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