Regulatory and Biosafety Challenges for Vaccines

Abstract

The global regulatory plan for vaccines provides a unique opportunity to develop safe and effective ones with assured quality. Methods used by regulators address challenges of new products and technologies and also increase understanding of benefits and risks of existing products. First, the laboratory-based regulatory sciences evolve correlates of immunity and safety; or improve the product characterization and potency assays. Second, these sciences design clinical trial tools to analyze novel benefit-risk methodologies for vaccines, and standardize regulatory processes. The aim of the Global regulatory agenda is to transform current national efforts into a coordinated execution plan to support worldwide immunization goals. In the current article, it has been defined the role of regulatory science to improved access to effective vaccines, and identified gaps that could be addressed through that. Also, the challenges of implementing a regulatory agenda have been investigated, and proposed strategies to resolve these gaps. In this way, an appropriate agenda will enable regulators, academics and other stakeholders to work in a coordinated way to innovate in the regulatory processes in support of global immunization goals.

Keywords

• vaccine regulation
• vaccine qualification
• vaccine standardization
• clinical trials
• biosafety