APEC Harmonization Center: challenges and issues relating to multiregional clinical trials in the APEC region.
The Asia-Pacific Economic Cooperation (APEC) Harmonization Center (AHC) was established in 2009 with the purpose of promoting harmonization of regulatory processes for drugs and medical devices. The AHC held three training workshops on multiregional clinical trials (MRCTs); these workshops provided forums for discussing the value and potential benefits of MRCTs. Participants from regulatory agencies, the pharmaceutical industry, and academia identified many issues and made recommendations for resolving major challenges with the aim of improving the capacity of the Asia-Pacific region to carry out MRCTs.
National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration, Cheongwon-Gun, Chungcheongbukdo, Republic of Korea.
K L
KL
Park
T G
TG
Kim
S K
SK
Seong
S Y
SY
Lee
S H
SH
Kim
D001208:Asia; D002986:Clinical Trials as Topic / Q000592:standards / Q000639:trends*; D004345:Drug Industry / Q000592:standards / Q000639:trends*; D004335:Drug and Narcotic Control / Q000639:trends; D004493:Education / Q000639:trends*; D006801:Humans; D007391:International Cooperation