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  • The regulation for shortening the period will be revised
  • by Lee, Hye-Kyung | translator Choi HeeYoung | Aug 16, 2022 05:46am
if PE exemption is applicable
The HIRA extends RSA targets to revise drug benefit assessment standards
As announced by the government, if the RSA-applied drugs are subject to PE submission, the registration period will be shortened, and even drugs that have proven improvement in children's quality of life will be excluded. The HIRA will pre-announce the "Partial Amendment Regulations on the Evaluation Standards and Procedures for Medical Care Benefits" containing such information and receive opinions by the 30th of next month. The revised regulations are designed to promote national tasks such as shortening the listing period of drugs related to diseases that threaten survival and strengthening access to patients through the expansion of risk-sharing systems.

In accordance with Article 11-2 (1) of the Medical Care B
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