Regulation and licensing of biological products in countries with newly developing Regulatory Authorities, Annex 1, TRS No 858

Adopted by ECBS 1994

Overview

Full version of the WHO Technical Report Series N° 858

National health authorities have the duty  to ensure that available pharmaceutical products whether imported or manufactured locally, are of good quality, safe  and efficacious. This is particularly difficult for vaccines and biological products, the quality of which cannot be established entirely by tests on the material in the final container.

 

 

WHO Team
Health Product Policy and Standards (HPS), Norms and Standards for Biological Products (NSB)
Number of pages
15
Reference numbers
WHO Reference Number: WHO TRS N°858
Copyright
World Health Organization