The assessment, licensure, control, and surveillance of biological medicinal products are major challenges for national regulatory authorities (NRA) who must deal with a steadily increasing number of novel products, complex quality concerns, and new technical issues arising from rapid scientific advances in the field of immunization. Increasing globalization of the pharmaceutical market also means that the volume of biological medicinal products crossing national borders is growing. It is therefore critical that regulatory knowledge and experience areshared and approaches to regulation harmonized to the greatest extent possible.

WHO applies a consultative approach to generating and consolidating consensus on key regulatory issues which it makes available through guidance documents that deal with both general issues and specific products. The availability of this guidances helps ensure that NRAs are informed about critical issues and aware of the regulatory approaches and methodologies that are considered to be optimal for ensuring the global supply of  safe, quality-assured and effective biological medicinal products.