Chapter 1 - Background

Abstract

The chapter explains the One World Health by World Health Organization (WHO). Prior to the International Conference on Harmonization (ICH), which brought the Global Cooperation Group (GCP) regulations in line across the USA, Europe, and Japan, the varied regulatory requirements for each country made international trials very onerous. The WHO is not a regulatory agency, but for many countries that cannot afford a robust regulatory system or have not yet developed one, the WHO is a very important source of validation for drugs and vaccines. The original intent was to help agencies such as UNAIDS, UNICEF, UNFPA, and the World Bank determine which drugs were of high and dependable quality. The packaging and labeling must meet the specific WHO requirements as outlined in the WHO International Guideline on Packaging and Shipping of Vaccine. The WHO's target is to complete the initial review of the application within three months. If the application is adequate, the WHO will test samples of the vaccine and perform site visits. Once the evaluation is complete, the WHO informs the sponsor, the NRA, and the UN agencies. In emergency cases, a fast-track process expedites the process. After the prequalification, reassessments are performed, usually every two years. The reassessment usually requires submission of information detailing changes to the product or manufacturing, retesting of samples, and a site visit, among other actions. There is, in addition, continual random testing of vaccine samples, as well as monitoring of complaints about the vaccines from the field.