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Need to specify conditions for postponing PE data submission

By Lee, Tak-Sun | translator Kim, Jung-Ju

24.01.04 12:09:53

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HRIRA discloses research service results...Proposes to exclude 'pediatric drugs' whose indication was extended a year ago


 ¡ãStudy on Improving the Pharmacoeconomic Evaluation Data Waiver (PE exemption) System


The results of the research service that was ordered by the Health Insurance Review and Assessment Service to devise measures on improving the pharmacoeconomic data submission waiver system, or the PE exemption system, have been disclosed in full.

The improvements suggested by the researchers include redesigning the PE exemption system into a PE deferral system, and establishing a process to demonstrate economic feasibility after listing. It was also suggested that a reevaluation system should be established for drugs that have already been listed through the PE exemption track.

Based on the study, HIRA plans to come up with a follow-up and reevaluation plan for the PE exemption d

Lee, Tak-Sun(hooggasi2@dailypharm.com)
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