Developing key performance indicators to measure the progress of regional regulatory convergence and cooperation in Asia-Pacific Economic Cooperation (APEC)

AAPS Open

Sannie Siaw Foong Chong¹  John C. W. Lim²  Toshiyoshi Tominaga³ 

[1] Asia Pacific Technical Regulatory Policy, Pharma Technical Regulatory Policy and International Operations, Roche Singapore Technical Operations, F. Hoffmann La-Roche Ltd;Centre of Regulatory Excellence, Duke-NUS Medical School;Pharmaceuticals and Medical Devices Agency (PMDA);

关键词: APEC;    Regulatory convergence and cooperation;    Key performance indicators;   

DOI  :  10.1186/s41120-018-0024-2

来源: DOAJ

【 摘 要 】

Abstract 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.

【 授权许可】

Unknown