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通过能力建设和培训实现生物制剂的监管趋同。

Regulatory Convergence for Biologics through Capacity Building and Training.

机构信息

Biopharmaceutical Analysis Training Laboratory, APEC RHSC Center of Regulatory Excellence in Biotherapeutics, Department of Chemistry and Chemical Biology, Northeastern University, Burlington, MA, USA.

出版信息

Trends Biotechnol. 2019 Jan;37(1):5-9. doi: 10.1016/j.tibtech.2018.06.001. Epub 2018 Jun 20.

Abstract

Several regulatory convergence efforts for biologics are underway globally, with the goal of ensuring global standards are applied consistently across regulatory agencies. Training and capacity building will ensure convergence through fostering international collaborations between agencies and ensure harmonized standards are applied, which will bring products to market faster and cheaper.

摘要

正在全球范围内开展几项生物制品监管趋同工作,目标是确保全球标准在各监管机构中得到一致应用。培训和能力建设将通过促进机构之间的国际合作来确保趋同,并确保采用协调一致的标准,从而更快、更廉价地将产品推向市场。

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