- Opinion
- [Reporter's View] Strengthening GMP for sterile drugs
- by Kim, Jin-Gu May 19, 2025 05:56am
- The government has reaffirmed its existing position on strengthening GMP standards for sterile finished drug products in December. The Ministry of Food and Drug Safety recently met with sterile drug factory managers and stated that there will be no postponement of the enforcement of the “Regulations on Drug Manufacturing and Quality Control
- Opinion
- [Reporter's View] Korea’s vaccination space: ups and downs
- by Eo, Yun-Ho May 15, 2025 06:23am
- Vaccines are at the forefront of localized pharmaceuticals in Korea. Leading domestic companies such as GC Biopharma and SK Bioscience are now responsible for vaccine production and supplying preventive vaccines for various diseases, including influenza. The commercialization of so-called “premium homegrown vaccines,” such as pneumococc
- Opinion
- [Reporter's View] USIM data leakage incident is a warning
- by Kim, Jin-Gu May 2, 2025 05:55am
- The SKT USIM data leakage incident has spread anxiety throughout society. Previously, there have been countless personal data security breaches, but the latest incident is considered differently. The scale of the expected damage is so large that it’s hard to estimate. Long lines have formed in front of SKT stores as people wait to replace th
- Opinion
- [Reporter’s View] Consideration in legislating telemedicine
- by Lee, Jeong-Hwan Apr 30, 2025 06:07am
- Following the presidential election on June 3, which will determine the next president and new administration, one of the most urgent healthcare policies that would need to be addressed is ‘non-face-to-face treatment,’ or telemedicine. Currently, two bills to formalize telemedicine, which is currently under pilot programs, are pending i
- Opinion
- [Reporter's View] Prescribing pre-reviewed new drugs
- by Eo, Yun-Ho Apr 30, 2025 06:06am
- New drugs that patients long-awaited are being reimbursed, but no hospitals are prescribing them. There have been various attempts at improving the system, but an issue related to new drug access remains unresolved in South Korea. Public petitions for reimbursement of a particular new drug are frequently listed, and more patient organi
- 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
