Liu Li-Ling, McAuslane Neil, Tzou Meir-Chyun, Chern Herng-Der, Liberti Lawrence, Ward Mike, Kang Jaw-Jou
1 Division of Medical Devices and Cosmetics, Food and Drug Administration, Taipei, Taiwan.
2 Centre for Innovation in Regulatory Science, London, UK.
Ther Innov Regul Sci. 2013 Nov;47(6):678-683. doi: 10.1177/2168479013494394.
As a first step in the implementation of the Asia-Pacific Economic Cooperation (APEC) Best Regulatory Practice Project, the Centre for Innovation in Regulatory Science conducted a gap analysis survey among regulatory agencies of 14 APEC member economies to assess the current use of good review practices (GRevP) to support transparent, consistent, predictable, and good-quality regulatory decision making. Although the majority of responding agencies have established some form of GRevP, most practices are currently evolving and are applied on an informal basis. Most agencies have developed standard operating procedures and guidelines and use a variety of training methods. The use of a common approach to regulatory review across jurisdictions would help build trust and confidence in each agency's processes, setting the stage for the possibility of work sharing across resource-constrained agencies and bringing consistency and transparency to the review process.
作为实施亚太经济合作组织(APEC)最佳监管实践项目的第一步,监管科学创新中心对14个APEC成员国经济体的监管机构开展了一项差距分析调查,以评估当前良好审评实践(GRevP)在支持透明、一致、可预测和高质量监管决策方面的应用情况。尽管大多数回复机构已建立了某种形式的GRevP,但目前大多数做法仍在不断发展,且以非正式方式应用。大多数机构已制定标准操作规程和指南,并采用多种培训方法。在各辖区采用统一的监管审评方法,将有助于增强对各机构程序的信任和信心,为资源有限的机构之间开展工作共享创造条件,并使审评过程具有一致性和透明度。