ABSTRACT

The complexity of the COVID 19 pandemic has created a chaos in human life. Although various anti-viral drugs available to treat the COVID 19 but during this emergency situation the only solution to save humans is development of new vaccines to stop the spread of this pandemic. This has changed the way regulators look at the approval of new drugs/vaccines. The vaccines are not yet fully developed, and these new vaccines require a lot of work and patience to get approved. The major concerns about the vaccines are safety efficacy studies which are not completely established. Regulators have been trying very hard to bring flexibility in regulations so as to accelerate the approval process by considering the current pandemic situation. Many regulatory authorities providing approvals through the clause of Emergency Use Authorization (EUA). In this scenario, this paper will cover about various regulatory authorities of India (CDSCO Central Drugs Standard Control Organization), USA (Unites States Food Drug Administration) and Europe (European Medical Agency) and their legal regulations for development, manufacturing, licensing, import/export of the products to various countries etc. Technical regulations such as clinical data assessment such as safety and efficacy evaluation by using toxicity studies, trail population, study design. Complete information about the Phase I, Phase II, Phase III and Phase IV. Administrative regulations of the three countries such as filing procedures, licensing procedure and approval timelines by the regulatory authorities. Many of the vaccines are under Phase II &Phase III trials. Since the Clinical data are not completely established the manufacturing organizations it becomes a huge challenge for the regulatory authorities to provide approval to the vaccine. Hence, they will only approve the vaccines only when the benefit to risk ratios exceed. All the manufacturing organizations shall submit complete data after even attaining Emergency Use Authorization this include complete Phase III data and Phase IV data such as adverse reactions and post market surveillance. There are about 150 vaccine candidates are under study as per the World Health Organization. The ultimate goal of the regulators is to protect the human subject from disease and provide them with effective medication. Key words: Covid-19, FDA, Clinical Trials, Regulations, CDSCO
Publication date: 01/12/2021

https://ijbpas.com/pdf/2021/December/MS_IJBPAS_2021_DEC_SPCL_2004.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.12.2004