Regulation of vaccines: building on existing drug regulatory authorities

Overview

WHO is often asked for advice by drug regulatory authorities (DRAs) and Ministry of Health officials to develop the capacity to regulate biological products, particularly vaccines. Although vaccines are generally included in the legal definition of pharmaceutical products, and thus would fall under the jurisdiction of DRAs, there are extra considerations that apply to their regulation and control.

These guidelines are based on analysis of activities to achieve this capacity in several countries. They have been jointly developed by the Department on Essential Drugs and Other Medicines (formerly Action Programme on Essential Drugs and the Division of Drug Management and Policies) and the Department of Vaccines and Other Biologicals (formerly the Global Programme for Vaccines and Immunization). They are based on existing WHO documents promulgated by WHO’s three Expert Committees, namely, on Biological Standardization, on Specifications for Pharmaceutical Preparations, and on the Use of Essential Drugs (key references are listed in Annex 1). They are intended for countries that have functioning DRAs, but which are not yet engaged in regulation and control of vaccines and other biologicals.