Immunization standards

Vaccine regulation

National regulatory authorities

The assessment, licensure, control, and surveillance of biological medicinal products are major challenges for national regulatory authorities confronted by a steadily increasing number of novel products, complex quality concerns, and new technical issues arising from rapid scientific advances. With the emerging global market the volume of biological medicinal products crossing national borders continues to rise, and it has become critical that regulatory knowledge and experience concerning them can be shared, and approaches to their control harmonized to the greatest extent possible.

Through its consultative approach, WHO identifies and consolidates current consensus opinions on key regulatory issues, and communicates them to national authorities and manufacturers through guidance documents addressing both general issues and specific products. Through this mechanism, national regulatory authorities are informed on the scientific background needed to assess critcal issues, and are advised on which regulatory approaches and methodologies have been found to be optimal for insuring the global supply of uniformly high, quality, and efficacious biological medicinal products.

SELECTED EXAMPLES OF GUIDANCE DOCUMENTATION TO REGULATORY AUTHORITIES:

UPCOMING EVENTS


  • WHO Informal Consultation on Regulatory considerations for evaluation of Ebola Vaccines intended for emergency use, WHO/HQ Geneva, Switzerland, 18-19 March 2015
  • WHO Informal Consultation on Stability Evaluation of Vaccines for use in a Controlled Temperature Chain, WHO/HQ Geneva, Switzerland, 24–26 March 2015
  • WHO Informal Consultation on Amendment for Similar Biotherapeutic products of monoclonal antibodies, WHO/HQ Geneva, Switzerland, 27–28 April 2015
  • WHO Informal Consultation on Regulatory risk assessment for biotherapeutic products, WHO/HQ Geneva, Switzerland, 29–30 April 2015

Contacts


Technologies Standards and Norms (TSN)
Essential Medicines and Health Products (EMP)
World Health Organization (WHO)
Avenue Appia 20
1211 Geneva 27, Switzerland
Fax No. +41 22 7914971