Comparative study on lot release systems for vaccines as of 2016

Abstract

Many countries have established their own vaccine lot release system, which fits each country’s situation, while the World Health Organization is promoting convergence in regulatory systems for vaccines so that vaccines of assured quality are provided globally. We conducted questionnaire-based investigation of the lot release systems for vaccines in seven countries and two regions. It was found that a review of the summary protocol by National Regulatory Authorities was commonly applied for independent lot release of vaccines, whereas there was diversity, especially in the testing policy. Some countries and regions, including Japan, conducted testing on every lot, while the other countries and regions conducted testing at reduced frequencies that had been determined according to the risk assessment of the products. Test items selected for lot release varied among the countries or regions investigated, although there was a tendency to prioritize the potency tests. An understanding of lot release policy may contribute to improving and harmonizing the lot release system globally in the future.