An international hybrid meeting held 21–22 June 2023 in Ottawa, Canada brought together regulators, scientists, and industry experts to discuss a set of principles and best practices in the development and implementation of standards. Although the use of international standards (ISs) and international units (IUs) has been an essential part of ensuring human and animal vaccine quality in the past decades, the types and uses of standards have expanded with technological advances in manufacture and testing of vaccines. The needs of stakeholders are evolving in response to the ever-increasing complexity, diversity, and number of vaccine products as well as increasing efforts to replace animal-based potency tests with assays that measure relevant quality attributes. As such, there must be a concomitant evolution in the design and implementation of both international and in-house standards. Concomitantly, greater harmonization of regulatory expectations must be achieved through collaboration with standard-setting organizations, national control laboratories and manufacturers. Stakeholders provided perspectives on challenges and several recommendations emerged as essential to advancing agreed upon objectives.

中文翻译：

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通过使用标准保持疫苗质量：当前的挑战和未来的机遇

2023 年 6 月 21 日至 22 日在加拿大渥太华举行的国际混合会议汇聚了监管机构、科学家和行业专家，讨论标准制定和实施的一系列原则和最佳实践。尽管在过去几十年中，国际标准（IS）和国际单位（IU）的使用一直是确保人类和动物疫苗质量的重要组成部分，但随着疫苗制造和测试技术的进步，标准的类型和用途也在扩大。利益相关者的需求正在不断变化，以应对疫苗产品不断增加的复杂性、多样性和数量，以及越来越多的努力用测量相关质量属性的测定法取代基于动物的效力测试。因此，国际和内部标准的设计和实施必须随之发展。与此同时，必须通过与标准制定组织、国家控制实验室和制造商的合作来实现监管期望的更大协调。利益相关者提供了对挑战的看法，并提出了一些对于推进商定目标至关重要的建议。