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Review period & material improved for COVID-19 Txs, etc.

By Lee, Jeong-Hwan | translator Alice Kang

21.11.26 12:03:11

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Prime Minister Boo-Kyum Kim announces ¡°Measure for regulatory innovation to address difficulties in the new industry¡±

MFDS ¡°Specified standards for items subject to priority review, such as evidence material, development details, manufacture method, etc.¡±

The government will lead the improvement of administrative effectiveness and predictability by preparing specific standards on the review period and scope of materials submitted for the marketing approval of pharmaceuticals.

The measure was made as means for the government to preemptively respond to the expedited approval of new drugs, anticancer drugs, orphan drugs, and infectious disease treatments such as COVID-19 drugs.

On the 25th, Prime Minister Boo-Kyum Kim held the 137th State Affairs Inspection and Coordination Conference and announced ¡°the 8th measure for regulatory innovation to address difficulties in the new industry¡±

The regulatory innovation that will direc

Lee, Jeong-Hwan(junghwanss@dailypharm.com)
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