APEC Harmonization Center: challenges and issues relating to multiregional clinical trials in the APEC region
Park, K.L.; Kim, T.G.; Seong, S.K.; Lee, S.Y.; Kim, S.H.
Clinical Pharmacology and Therapeutics 91(4): 743-746
2012
ISSN/ISBN: 0009-9236 PMID: 22318621 DOI: 10.1038/clpt.2011.344Document Number: 309380
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.