Concept Paper on the development of a Guideline on the 4 quality aspects of mRNA vaccines

Concept Paper on the development of a Guideline on the 4 quality aspects of mRNA vaccines

Concept Paper

The published document from the European Medicines Agency addresses the need to establish a guideline on the quality aspects of mRNA vaccines. In recent years, the number of applications for clinical trials for human medicinal products as well as for marketing authorization for mRNA-containing medicinal products has increased significantly and is expected to continue to increase in the near future. From an analytical and regulatory perspective, mRNA vaccines are of interest because their classification depends on the target and/or whether they are derived by chemical or biological means. mRNA vaccines against infectious diseases must comply with the current guidelines for human vaccines. However, this new technology is not fully addressed in the existing documents. It is therefore proposed that a guideline be developed to address the specific aspects of the manufacturing process, characterization, specifications, and analytical control, as well as the definition of the active ingredient and finished product