Regulatory Requirements For MRNA-Based Therapeutics As Per CDSCO (India) in comparison with Swissmedic (Switzerland)

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1. [1]The success of mRNA vaccines during the COVID-19 pandemic increased interest in using this technology for other diseases. In India, important areas of research include infectious diseases, cancer, rare genetic disorders, and personalized medicine. The Swiss mRNA therapeutics market is supported by increasing investment in biotechnology and growing interest in precision medicine. Research is expanding into cancer, infectious diseases, rare genetic disorders, cardiovascular diseases, and regenerative medicine. Switzerland has a strong focus on advanced therapeutic research, particularly oncology, precision medicine, rare genetic disorders, and regenerative medicine. Lastly, we are grateful to all those people who have been instrumental in the completion of this article. National Library of Medicine (US), National Institutes of Health. mRNA therapeutics [Internet]. Bethesda (MD): National Institutes of Health; 2023 [cited 2025 May 24]. Available from: https://ncbi.nlm.nih.gov National Center for Biotechnology Information (US). NCBI [Internet]. Bethesda (MD): National Library of Medicine; [cited 2025 May 24]. Available from: https://www.ncbi.nlm.nih.gov PubMed Central (US), National Library of Medicine. PubMed Central [Internet]. Bethesda (MD): National Institutes of Health; [cited 2025 May 24]. Available from: https://www.ncbi.nlm.nih.gov/pmc/ Swissmedic. New regulatory provisions from 1 November 2024 [Internet]. Bern: Swissmedic; 2024 [cited 2025 May 24]. Available from: https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/neues-verordnungsrecht-ab-1-nov-2024.html Swissmedic. Revised regulatory provisions concerning the Human Research Act [Internet]. Bern: Swissmedic; [cited 2025 May 24]. Available from: https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/klv-revidiertes-verordnungsrecht-humanforschungsgesetz.html Swissmedic. Implementation of regulatory provisions for clinical trials on medicinal products [Internet]. Bern: Swissmedic; [cited 2025 May 24]. Available from: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/clinical-trials/clinical-trials-on-medicinal-products/implementierung-verordnungsrecht.html Central Drugs Standard Control Organization. Imports [Internet]. New Delhi: Government of India; [cited 2025 May 24]. Available from: https://cdsco.gov.in/opencms/opencms/en/Departments/Headquarters/imports Central Drugs Standard Control Organization. Guidance document: cold chain compliance [Internet]. New Delhi: Government of India; [cited 2025 May 24]. Available from: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/Guidance_doc Central Drugs Standard Control Organization. Vaccines: regulatory compliances [Internet]. New Delhi: Government of India; [cited 2025 May 24]. Available from: https://cdsco.gov.in/opencms/opencms/en/biologicals/Vaccines Swissmedic. Advanced therapy medicinal products (ATMPs) [Internet]. Bern: Swissmedic; [cited 2025 May 24]. Available from: https://www.swissmedic.ch/swissmedic/en/home.html Swissmedic. Market authorization [Internet]. Bern: Swissmedic; [cited 2025 May 24]. Available from: https://www.swissmedic.ch/swissmedic/en/home.html

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