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:
Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks
Good manufacturing practices for biological products
Quality assurance for biological products, guidelines for national authorities
Regulation and licensing of biological products in countries with newly developing regulatory authorities
Thiomersal for vaccines: regulatory expectations for elimination, reduction or removal
Vaccines, clinical evaluation: regulatory expectations
WHO guidelines on Transmissible Spongiform Encephalopathies in relation to Biological and Pharmaceutical Products
- WHO Informal Consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products including biosimilars, Seoul, Republic of Korea, 27-28 April 2017
- Working Group meeting on revision of WHO TRS 941, Annex 5: WHO biosafety risk assessment and Guidelines for the production and quality control of human influenza pandemic vaccines, Geneva, Switzerland, 9-10 May 2017
- Working group meeting on Hepatitis E Vaccine, Geneva, Switzerland, 11-12 May 2017