- 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
- Opinion
- [Reporter's View] ‘Tyranny of Drug Committees persist'
- by Eo, Yun-Ho Sep 11, 2024 05:54am
- Even after a drug is approved by the Ministry of Food and Drug Safety and listed for reimbursement, the drug cannot be prescribed immediately by medical staff at general hospitals. A drug can only be prescribed at each hospital after a prescription code is generated upon review by their respective drug committees (DCs). The process, in
- Opinion
- [Reporter’s View] Vaccine sovereignty only during epidemics
- by Son, Hyung-Min Sep 5, 2024 05:51am
- The Korea Disease Control and Prevention Agency recently announced that it will support messenger ribonucleic acid (mRNA) vaccines in preparation for the next pandemic. The government will support research and development from preclinical to Phase III trials, focusing on companies with the potential to localize mRNA vaccine platforms. Ca
- Opinion
- [Reporter's View] pros and cons of concurrent reimb listing
- by Eo, Yun-Ho Aug 30, 2024 05:49am
- When there are no changes to demand, increased supply reduces prices. This model of price determination can be applied to the pharmaceutical market. For pharmaceuticals, inducing competition between pharmaceutical companies can decrease financial expenses. However, it often results in increased time for reimbursement listing. Drug price
- Opinion
- [Reporter’s View]Support domestic COVID-19 drugs
- by Lee, Hye-Kyung Aug 28, 2024 05:52am
- The recurrence of COVID-19 has sparked interest in COVID-19 drugs. After the pandemic turned into an endemic, the government set a budget of KRW 179.8 billion for COVID-19 drugs this year, which was a 53.2% cut from last year, and the number of COVID-19 drugs introduced in Q1 and Q2 of this year was 179,000, half of the 341,000 that the gove
