- Opinion
- [Reporter's View] Enhanced GMP reg for sterile drug products
- by Lee, Hye-Kyung Apr 28, 2025 05:55am
- Starting December 27, production·good manufacturing practices (GMP) regulations for sterile medicinal products produced by aseptic processing will be strengthened. The Ministry of Food and Drug Safety (MFDS) amended the 'Regulations on Good Manufacturing Practices (GMP) for Medicinal Products' in 2023. The revision had been conducted to
- Opinion
- [Reporter's View] Reimb criteria for cancer therapy
- by Whang, byung-woo Apr 23, 2025 06:11am
- The Ministry of Health and Welfare (MOHW) has recently issued an administrative notice announcing an improvement to the National Health Insurance-covered reimbursement criteria for combination cancer therapy. The revised policy states that the patient's co-payment will remain the same as the previously initiated treatment regimen, even if
- Opinion
- [Reporter’s View] Discuss indication-based pricing
- by Son, Hyung Min Apr 23, 2025 06:09am
- The need for a drug pricing system based on indications, which has been consistently raised by the pharmaceutical industry, is reemerging. Recently, some multinational pharmaceutical companies are preparing to hold a “Discussion on Policies to Resolve Inequality in Innovative New Drugs and Improve Regulations.” In particular, the forum
- Opinion
- [Reporter's View] The MOHW’s contradiction
- by Lee, Jeong-Hwan Apr 16, 2025 05:55am
- The Ministry of Health and Welfare cited the 'non-face-to-face medical treatment pilot project' as an excellent administrative example last year. The reason for its excellence is that the non-face-to-face treatment, which was urgently and temporarily permitted in February 2020 in response to the COVID-19 pandemic, was converted into a pilot
- Opinion
- [Reporter's View] 'Korea Passing' related to new drugs
- by Eo, Yun-Ho Apr 14, 2025 05:57am
- The same term can be interpreted differently. In the pharmaceutical industry, 'Korea Passing' is not a matter of diplomatic conflicts. The issue is not analogous to the United States and North Korea alienating South Korea, but it related somewhat to a single multinational pharmaceutical company alienating South Korea due to drug pricing
- Opinion
- [Reporter's View] Korean R&BD system and strategies
- by Whang, byung-woo Apr 10, 2025 05:57am
- “It is not easy for a new drug to succeed just with good technology. It is only a real success when the drug reaches the market.” This is what an executive of a global pharmaceutical trading company said to the reporter recently. The tides are changing in the pharmaceutical and biopharmaceutical industry. The focus is shifting from R&D
- Opinion
- [Reporter's View] Why clinical outcomes require deliberation
- by Son, Hyung Min Apr 8, 2025 05:57am
- Even small differences in clinical outcomes can be highly meaningful. Especially for refractory diseases. Recent top&8208;line results from Compass Therapeutics’ Phase 2/3 COMPANION-002 trial for cholangiocarcinoma have sparked considerable debate within the industry. According to Compass Therapeutics, the treatment of bispecific ant
- Opinion
- [Reporter's View] Preparations for US pharmaceutical tariff
- by Kim, Jin-Gu Apr 3, 2025 05:55am
- US President Donald Trump designated April 2 (local time) as 'America's Day of Liberation.' The day the US will announce reciprocal tariff rates for various countries. US reports expect details on tariff-affected countries, rates, and applicable product categories to be disclosed as early as the evening of the 1st. The specific tariff rat
- Opinion
- [Reporter's View]Unifying the price of pneumococcal vaccines
- by Eo, Yun-Ho Mar 28, 2025 06:38am
- The National Immunization Program (NIP) is the ideal “goal” for vaccine-holding pharmaceutical companies. This is because the government's policy of purchasing vaccines and providing them free of charge to the public, above all, ensures stable sales. Therefore, when the government announces that it has selected a preventive vaccine for
- Opinion
- [Reporter's View] Healthcare AI and diversity·expandability
- by Whang, byung-woo Mar 28, 2025 06:37am
- During the 'KIMES 2025,' held last week, artificial intelligence (AI) gained the most attention. The exhibition booths were filled with companies that showcased AI at the forefront, including hospital systems and diagnostic imaging to patient monitoring, chatbot consultations, and electronic medical records (EMR). Large booths prominently
