Opportunities for improving access to vaccines in emerging countries through efficient and aligned registration procedures: An industry perspective

Abstract

Vaccines play an essential role in preventing infectious diseases. Their registration in importing countries is often cumbersome and unpredictably lengthy, leading to delays in vaccine access for populations that need them most. This report builds on a previous publication identifying challenges for registration of vaccines in emerging countries. As a matter of social responsibility, it was judged necessary to address the challenges and offer a set of solutions for open dialogue. Based on regular exchange of information and experiences, a group of regulatory experts from the vaccine industry developed three sets of proposals for consideration by vaccine stakeholders, with a view to improving the situation, by fostering regulatory convergence, with viable options for streamlining registration procedures through reliance on other experienced regulators or international agencies. Further, it offers options for alignment of structure and contents of Common Technical Document modules and presents a harmonized template application form that could potentially be used by all countries.

Keywords: CTD; Inspection; Procurement; Registration; Reliance; Testing.