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2024-11-03 12:32
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Opinion
[Reporter's View] Address Actions to drug substitution
by
Lee, Jeong-Hwan
Nov 1, 2024 05:51am
"We will foremostly activate drug substation to resolve the drug shortages issue," Cho Kyoo-hong, Minister of Health and Welfare (MOHW), promised during the parliamentary audit session commenced by the National Assembly's Small Committee for Health and Welfare. This is an answer from the MOHW director to an issue of essential medicines fr
Opinion
[Reporter's View] Super precision medicine
by
Eo, Yun-Ho
Oct 30, 2024 05:53am
Super Precision medicine. New drugs have been developed to selectively target with more significant efficacy than before. Lately, news articles related to anticancer agents have frequently covered keywords related to genetic mutations, including MET, RET, ALK, EGFR, and ROS1. Customized treatments are becoming available, where effective t
Opinion
[Reporter¡¯s View] Deadlines are set for a reason
by
Eo, Yun-Ho
Oct 17, 2024 05:51am
The definition of ¡®deadline¡¯ is a time limit set in advance. So what is the right thing to do if the deadline has ended without a conclusion being made? Providing a justifiable explanation is very important in administrative affairs. Explanations are necessary not only in the course of introducing or abolishing a system, but also when e
Opinion
[Reporter's view] Expanding NIP to include 9-vHPV
by
Whang, byung-woo
Oct 16, 2024 05:50am
Several treatment-related agenda items were discussed during this year's parliamentary audit of the Ministry of Health and Welfare (MOHW). Various current measures, including improvements to the drug pricing system and blood cancers, have been discussed. One is the necessity of including human immunodeficiency virus (hereafter referred to
Opinion
[Reporter's view] Creating a virtuous cycle for K-bio growth
by
Son, Hyung Min
Oct 11, 2024 05:54am
The research and development (R&D) trend in the biopharmaceutical industry is focusing on new anticancer drugs. The field is gaining interest, especially following the clinical success of Yuhan Corp's Leclaza (ingredient: Lazertinib) and HLB's rivoceranib. In particular, most biotech companies in South Korea are confirming the clinical po
Opinion
[Reporter's View]Industry expectations rise with new changes
by
Eo, Yun-Ho
Oct 10, 2024 05:50am
The criteria for innovative new drugs that are eligible for the flexible application of the ICER threshold and the measures for the expansion of the risk-sharing agreement (RSA) have been revealed. As always, the industry expressed a mix of expectations and concerns. The disclosed ¡®Detailed evaluation criteria for new drugs etc. subject
Opinion
[Reporter¡¯s View]Contradictions in the CSO reporting system
by
Kim, Jin-Gu
Oct 7, 2024 05:48am
The implementation of the CSO reporting system is now just 2 weeks away. It means that after the 19th of this month, no one will be able to engage in sales and promotion activities in the pharmaceutical industry without a CSO report certificate. Although there are only 2 weeks left until the law takes effect, there is still confusion amo
Opinion
[Reporter¡¯s View] How to increase the new drug approval fee
by
Whang, byung-woo
Sep 26, 2024 05:51am
The Ministry of Food and Drug Safety (MFDS) decided to significantly raise its new drug approval fee to expand its capability for the prompt review of newly developed drugs. The fee for new drug approval, which was previously KRW 8.83 million, was increased 48 times to KRW 410 million based on the benefit principle. Despite the dramati
Opinion
[Reporter¡¯s View] The new drug approval fee hike
by
Lee, Hye-Kyung
Sep 19, 2024 05:48am
The Ministry of Food and Drug Safety has announced an amendment to the ¡°Fee Regulations for the Approval of Drugs, etc.¡± that will significantly increase the fee for new drug approvals from KRW 8.83 million to KRW 410 million. This is the first time in 4 years that the government has decided to increase the new drug approval fee, which is
Opinion
[Reporter¡¯s View] Benefits of the U.S. Biosecure Act
by
Son, Hyung Min
Sep 13, 2024 05:50am
The US House of Representatives recently passed the Biosecure Act, which includes the US¡¯s biological sanctions against China. The bill will now head to the US Senate for voting and go through a presidential review process for legislation. The Biosecure Act restricts transactions with major Chinese biotech companies that the U.S. Congres
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