MARKETING AUTHORIZATION APPLICATION REQUIREMENTS FOR VACCINES IN INDIA, EUROPEAN UNION, UNITED STATES
SUHAS SHANKAR JOSHI
Pharmaceutical Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, S S Nagar, Mysuru-570015, India.
V. BALAMURALIDHARA *
Pharmaceutical Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, S S Nagar, Mysuru-570015, India.
*Author to whom correspondence should be addressed.
Abstract
Vaccines contain agents which are often made from the microbe or its surface proteins or its toxins, which are eventually derived from the biological source. Before launching a new vaccine in the market, the rigorous regulatory procedure is required to assess the quality, efficacy and safety of the vaccine. U.S. Food and Drug Administration (FDA) Centre for Biologics Evaluation and Research (CBER) is responsible for regulating vaccines in the United States. European Union (EU) follows five steps to regulate vaccine registration and regulation which are, marketing authorization application (MAA), registration, quality assessment, pharmacovigilance, post-license commitments and license renewals. In the case of India, vaccine registrations are regulated by the Drugs and Cosmetics Act, 1940.
Keywords: Centre for biologics evaluation and research, marketing authorization application, european union, food and drug administration, vaccines.