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Developing key performance indicators to measure the progress of regional regulatory convergence and cooperation in Asia-Pacific Economic Cooperation (APEC)
AAPS Open Pub Date : 2018-05-31 , DOI: 10.1186/s41120-018-0024-2
Sannie Siaw Foong Chong , John C. W. Lim , Toshiyoshi Tominaga

Regulatory convergence and cooperation among the authorities in the field of medical products (medicines and medical devices) are essential to deliver safe and efficacious products quickly to patients. APEC established the Regulatory Harmonization Steering Committee (RHSC) to advance this cause among member economies. This paper identifies four areas of appropriate regulatory practice in which APEC economies could converge, and explores the feasible processes of how APEC economies could cooperate in order to bring about realization of a maximum level of regulatory convergence by 2020.

中文翻译:

制定关键绩效指标以衡量亚太经合组织(APEC)区域监管融合与合作的进展

医疗产品(药品和医疗设备)领域的主管部门之间的监管融合与合作对于快速向患者提供安全有效的产品至关重要。亚太经合组织成立了监管协调指导委员会(RHSC),以在成员国经济体之间推进这一事业。本文确定了APEC经济体可以融合的四个适当监管实践领域,并探讨了APEC经济体如何合作以在2020年实现最大程度的监管融合的可行过程。
更新日期:2018-05-31
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