Regulatory considerations for messenger RNA vaccines: A comprehensive review on World Health Organization guidelines on development, production, and clinical evaluation

Abstract The messenger RNA (mRNA) vaccines have revolutionized vaccine development by enabling faster production compared to traditional methods. Comprehensive regulatory requirements for mRNA vaccines are required to ensure uniform quality, safety, and efficacy in this rapidly growing technology. Globally accepted World Health Organization (WHO) guidelines provide broad, adaptable recommendations to all national regulatory authorities, whereas others, such as the European Medicines Agencies (EMA’s) draft guideline, provide European Union specific legally binding, highly detailed technical requirements such as impurity thresholds, validated functional testing, and strict stability protocols. The distinctions reflect WHO’s function as a worldwide standard-setter against EMA’s regional enforcement responsibilities. For India, as one of the world’s major vaccine producers and a significant supplier to numerous countries and UN agencies, relying exclusively on WHO’s generalized framework may be insufficient. India presents unique issues such as varying population needs, disease burdens, and cold chain infrastructure limits. Developing India-specific mRNA vaccination rules that are aligned with WHO and incorporate analytical detail from EMA would boost domestic innovation, facilitate global export acceptance, and assure swift, safe responses to future public health catastrophes.