2022-11-12-世界卫生组织-Main_outcomes_of_the_meeting_of_the_Expert_Committee_on_Biological_Standardization_held_from_24_to_28_October_2022_5页_147kb

WHO ECBS Meeting Summary (October 2022)

• Meeting Overview: The 76th WHO Expert Committee on Biological Standardization (ECBS) meeting took place virtually from October 24 to 28, 2022. It addressed biological standardization issues, including COVID-19 pandemic responses and other key topics. Decisions and recommendations were finalized during a closed session.

• Adopted WHO Written Standards:

  • Recommendations for assuring quality, safety, and efficacy of oral poliomyelitis vaccine (OPV), revised to incorporate new technologies like high-throughput sequencing and post-eradication considerations.
  • Global model regulatory framework for medical devices, including in vitro diagnostic medical devices, updated to cover regulatory pathways and risk-based approaches.

• Established WHO International Reference Materials: Recommended 20 new and four replacement reference materials, along with endorsement for future materials. These include standards for biotherapeutics, blood products, cell and gene therapies, in vitro diagnostics, and pandemic-related substances like anti-SARS-CoV-2 immunoglobulins and variants.

• Key Discussions:

  • COVID-19 pandemic challenges in maintaining reference standards.
  • Addressing confusion in antibody unit assignments and proposing a working group for harmonization.
  • Cell and gene therapies: Barriers to regulatory harmonization and need for guidance improvements.
  • High-throughput sequencing applications in vaccine quality control and future WHO guidance.
  • Standardization of monoclonal antibody Fc domain characterization for therapeutic use.

• Upcoming Meetings: Scheduled for March 2023 and October 2023.