- Opinion
- [Contribution] On MFDS’s new drug approval fee hike
- by Whang, byung-woo Nov 21, 2024 05:46am
- The Ministry of Food and Drug Safety recently announced a significant rise in its new drug approval fee to KRW 410 million. In Korea, the new drug approval fee had remained very low at KRW 8.83 million for decades, compared to the US FDA's KRW 5.3 billion, the European EMA's KRW 490 million, and the Japanese PMDA's KRW 430 million.&160;
- Opinion
- [Reporter’s View] Who’s to blame the new drug reimb delays
- by Eo, Yun-Ho Nov 15, 2024 05:49am
- Expedited approval of new drugs is one of the oldest issues in the pharmaceutical industry. Shortening the insurance reimbursement review period for drugs has been discussed almost every year, and in fact, the regulatory deadline is getting shorter and shorter. This is true for both the evaluation and negotiation stages of the Health Ins
- Opinion
- [Reporter's View] The reality of drug shortage reports
- by Lee, Hye-Kyung Nov 14, 2024 05:52am
- Reports of shortages of oxytocin, an injectable drug used primarily as a labor inducer, have caused confusion in the obstetrics and gynecology field. Most obstetrics and gynecology centers that have a large number of expectant mother visits stock enough oxytocin to last 2-3 weeks, but JW Pharmaceuticals, which holds more than 70% of the pres
- Opinion
- [Reporter's View] voluntary resignation with compensation
- by Lee, Seok-Jun Nov 13, 2024 05:54am
- As the year-end is nearing, several pharmaceutical companies are considering restructuring. Rumor has it that these companies may have plans for reducing OTC businesses and laying off staff who are age 55 or older. It remains uncertain whether it is a rumor or an actual plan, but restructuring could be possible. Over five pharmaceutical comp
- Opinion
- [Reporter's View] Patience is required to foster K-Bios
- by Whang, byung-woo Nov 12, 2024 05:51am
- The performance of the domestic pharmaceutical bio industry is being evaluated with the approaching end of 2024. This year, the increased influence of domestic companies in the fields of biosimilars and CDMOs (contract development and manufacturing) and the technology transfer performance of bio ventures have been positively evaluated.&1
- Opinion
- [Reporter's View] Regarding the obesity drug craze
- by Son, Hyung Min Nov 8, 2024 05:46am
- There is one research and development item that is gaining explosive popularity among both global and domestic pharmaceutical companies &8211;obesity treatment. The use of obesity drugs has also increased dramatically with the significant rise in the number of obese people around the world. Global sales of obesity drugs reached USD 6.68
- 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
