APEC Pharmaceutical Evaluation Report (PER) Scheme: A Regional Solution for Global Drug Development

Abstract

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.

Keywords

Pharmaceutical Evaluation Report (PER) scheme Regional harmonization Global drug development APEC Life Science Innovation Forum (LSIF)

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References

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Chern

Unpublished data at Center for Drug Evaluation, Taiwan.