2003-09-15-世界卫生组织-WHO_Guidelines_on_Transmissible_Spongiform_Encephalopathies_in_relation_to_Biological_and_Pharmaceutical_Products_29页_119kb

WHO Guidelines on Transmissible Spongiform Encephalopathies (TSEs)

The emergence of variant Creutzfeldt-Jakob Disease (vCJD) in the mid-1990s increased global health concerns about Transmissible Spongiform Encephalopathies (TSEs), primarily due to the BSE epidemic in the UK. BSE-contaminated beef products were linked to vCJD, raising fears about the spread of TSEs through biological and pharmaceutical products.

Scientific Developments

Significant progress in understanding TSEs:

• Improved epidemiology, clinical features, and diagnostic criteria for CJD and vCJD.
• Epidemiology and control measures for BSE.
• Better characterization of infectivity distribution in tissues and diagnostic methods like PrPTSE.

Recommendations

Measures to Minimize Risks

• Risk Assessment: Evaluate materials used in product manufacturing.
• Source Materials: Use materials from BSE-free regions or low-risk herds. Avoid high-risk materials.
• Tissue Processing: Employ manufacturing processes that reduce infectivity risk.
• Production Systems: Specified measures for vaccines, recombinant products, and other pharmaceuticals.

Conclusion

These guidelines emphasize the need for regulated use and sourcing of materials from low-risk origins, refer to the development of safer alternatives for materials of bovine or other animal origin, and advise on blood product treatments due to potential TSE transmission risks. National and international alignment of policies is encouraged.