Regulatory Framework: Vaccine Development in Us, India and Eu

Abstract

Vaccine development usually takes around 7 y to come to the market after getting necessary regulatory approvals. But recent pandemics like Covid, Ebola, Swine Flu, have resulted in the collaboration of efforts between the government doing investments in vaccine development, academia, regulatory bodies, and industry. This has shortened the timelines for approval for vaccines. In 2009, HINI, Swine flu vaccines took 93 d for identifying the vaccine candidate for clinical trials. In 2014, for Ebola vaccine, it was deployed while the epidemic was still going on. Ebola vaccine was developed in 5 y. In case of Covid (SARS-CoV-2) clinical trials were approved when 2 mo of the pandemic onset. Within a time of 9 mo about 138 vaccine candidates are being reviewed for approval of EUA. This highly helps in the shortening of vaccine development and necessary approval. In this paper, we focused on the regulatory framework of vaccine development in INDIA, US and EU.

Regulatory requirements in the preparation CTD and ECTD as Per CDSCO comparison with Brazil

“…CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO) regulates the nation's registered medical devices, cosmetics, and pharmaceuticals for quality. [1] It is the National Drug Regulatory Authority of the Government of India and is in charge of establishing drug standards, approving clinical trials, monitoring the quality of imported drugs, coordinating the work of state drug control organizations, and giving professional advice in order to ensure consistency in the application of the drugs and cosmetics laws.Cosmetics Act in addition to the granting and renewal of licenses for certain key categories of drugs such blood and blood products, intravenous fluids, vaccines, sera, r-DNA products, and medical devices. The Indian government is currently working to improve the standards of the nation's regulatory practices and introduce a high level of uniformity in these activities.…”