Introduction of Vaccine Regulation
Development of vaccine is a long and complicated process, including research and exploratory stage, non-clinical trials stage, clinical trials stage, registration, and post-marketing safety surveillance. To ensure the quality, safety and efficacy of vaccine products, there are various regulations have been stipulated in Taiwan, for developers to follow. And those regulations are generally comparable with global standards. This article will outline the current vaccine regulations from pre-marketing to post-marketing status.