APEC Pharmaceutical Evaluation Report (PER) Scheme: A Regional Solution for Global Drug Development
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Chih-hwa Lin, PhD Director, Division of Resource Development, Centerfor Drug Evaluation, Taipei, Taiwan Bing Bing Lin, PhD, IMBA Principal Researcher. Division of Resource Development, Center for Drug Evaluation. Taipei, Taiwan; Adjunct Assistant Professor, Department of Business Administration and Department of Healthcare Management, Chang Gung University, Tao Yuan. Taiwan Herng-Der Chern, MD, PhD Executive Director. Center for Drug Evaluation, Taipei, Taiwan
Key Words Pharmaceutical Evaluation Report (PER) scheme; Regional harmonization; Global drug development; APEC Life Science Innovation Forum (LSIF) Correspondence Address Herng-Der Chern. MD, PhD. Centerfor Drug Evaluation. JENo. IS-J,Sec. 1. Hangiou S . Rd.. Taipei 100, Taiwan (email: hdchern @cde.org. tw).
APEC Pharmaceutical Evaluation Report (PER) Scheme: A Regional Solution for Global Drug Development L
INTRODUCTION Global drug development has become a common practice for drug development and marketing. However, the pace and the execution of this practice would require a harmonization of the drug review process, which is not practical due to ethnic and economic concerns in a heterogeneous region such as Asia. A proposal to adopt a Pharmaceutical Evaluation Report (PER) scheme for regulatory dialogue in Asia was made from Taiwan in the APEC Life Science Innovation Forum (LSIF) in Peru in 2008 to overcome the heterogeneous situation. The PER scheme was recommended to the APEC leadership (1).
H I S T O R Y O F PER S C H E M E The PER scheme was started on June l3,1979, with Austria, Norway, Finland, Sweden, and Switzerland as charter members. Eventually, it was extended to 17 participating regulatory authorities, 21 at its peak, mostly European countries, but also included Australia, Canada, New Zealand, and South Africa. The original purpose for the PER scheme is to facilitate. with due regard to public health aspects, trade in pharmaceutical products among the participating regulatory authorities through the exchange of evaluation reports, with the consent of the license holders (2,3). Why was the PER scheme needed? Because
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A proposal to adopt a Pharmaceutical Evaluation Report (PER) scheme for regulatory dialope in the Asia-Pacific Economic Coopemtion (APEC) region was madeftom Taiwan in the APEC life Science Innovation Forum (LSIF) in Peru in 2008, aiming to overcome the heterogeneous situation. 'Ihe PER scheme was recommended to the APEC leadership. 'Ihe history of the PER scheme, the reasons why the scheme is needed, and its benefits are discussed.
every regulatory agency faces the same dilemma: that they have limited resources, and they have to review the same amount of information on each new drug either in parallel or in sequence. In Europe, they have the concept that if you want to ensure quality,then you should have two independent agencies review the same data. So with this double evaluation they can compare and contrast the assessment report. The most unique feature of the PER scheme is that it is an open exchange system. That is, th
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