Vaccines are the most important health intervention. A vaccine is a biological preparation which increases the immunity to a specific disease. The development of a vaccine is a complex and tedious process. A strict regulatory process to determine the safety, efficacy, and quality must be achieved throughout the development of a vaccine for its authorization. In the USA vaccines are regulated by the Center for Biologic Evaluation and Research (CBER) under the USFDA. In Europe, vaccines are regulated by the European Medicines Agency (EMA) and authorization is granted by the European Commission (EC). In Canada, vaccines are regulated by Biologics and Genetics Therapy Directorate (BGTD) under Health Canada (HC). For Registration of Vaccine, Biologics license application (BLA) in the USA, Marketing authorization application (MAA) in Europe and New Drug Submission (NDS) Application in Canada should be submitted. After the registration of a vaccine, post-marketing surveillance system such as Vaccine Adverse Event Reporting System (VAERS) in the USA, Pharmacovigilance system in Europe and Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) in Canada monitors the safety of a vaccine.
