A proposal to adopt a Pharmaceutical Evaluation Report (PER) scheme for regulatory dialogue in the Asia-Pacific Economic Cooperation (APEC) region was made from Taiwan in the APEC Life Science Innovation Forum (LSIF) in Peru in 2008, aiming to overcome the heterogeneous situation. The PER scheme was recommended to the APEC leadership. The history of the PER scheme, the reasons why the scheme is needed, and its benefits are discussed.
ChernHDPartnership in harmonization with a proposal of APEC Pharmaceutical Evaluation Report (PER) scheme from Taiwan. Presented at the APEC Life Sciences Innovation Forum, Peru, August 14, 2008.
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