Listing period for new drugs to be reduced up to 60 days

By Kim, Jung-Ju | translator Alice Kang

22.06.15 06:00:52

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Chang-Hyun Oh, Director of Pharmaceutical Benefits at MOHW, announces plan to revise relevant regulations by September

Companies subject to reimbursement reassessments this year will receive 1st notice by next month … assessments to be conducted sequentially after collecting opinions in August

The overseas reference standards that will be created will be used in reassessments… govnt accepts request to extend data submission period for generic drug pricing reform

The government will reduce the new drug reimbursement listing procedures by up to 60 days to reinforce accessibility to new drugs. Also, the government plans to expand pharmacoeconomic evaluation (PE) exemptions, a mechanism that plays a key role in the deliberations made on the reimbursement adequacy of new drugs.

This is a specified plan set by the Ministry of Health and Welfare based on the national pledge that was presented by the Yoon administration to reinforce access to new drugs using the Risk-sharing Assessment (RSA) system. Based on the specificities that were planned, relevant regulations of the Health Insurance Review and Assessment Service (HIRA) and National Health Insurance Service (NHIS

Kim, Jung-Ju(jj0831@dailypharm.com)

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