Vaccinations are amongst the most important and powerful preventive measures modern medicine has to offer. By their nature, vaccines represent a very complex class of biological medicines. Licensure of novel vaccines is a process conducted on the basis of a comprehensive set of well-defined legal and procedural requirements. The key aim of the regulatory evaluation of vaccines is to confirm their pharmaceutical quality, safety, and efficacy in order to conclude on the positive benefit/risk ratio that is an absolute prerequisite for granting a license.In Europe there exist four types of licensing procedures for human vaccines (national, MRP, DCP, and centralized) depending on whether the vaccine is intended to be marketed nationally, in several, or all EU countries. Modern innovative vaccines are mostly licensed via the centralized EU procedure, which also offers a certain degree of procedural flexibility for specific vaccines under defined conditions. However, the basic regulatory requirements are the same for all types of licensing procedures. In order for a license to be granted, a vaccine has to fulfill all relevant regulatory requirements as regards pharmaceutical quality, including each manufacturing and control step as well as preclinical and clinical characterization. Most importantly, clinical trials in humans conducted prelicensure to determine vaccine safety and efficacy play a key role during the licensing procedure and for decision making.The WHO prequalification procedure was implemented to enable worldwide access to medicines of approved quality. Its prime aim is to establish and ensure appropriate universally recognized regulatory standards for vaccines to be used throughout the entire world.
Keywords: Benefit/risk ratio; Efficacy; Licensure procedures; Safety; Vaccination.