- 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
- Policy
- Will Enhertu be reimb for HER2-low cancer in Korea?
- by Whang, byung-woo Apr 28, 2025 05:55am
- Results of the deliberation on the reimbursement expansion of the new antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) for HER2-low breast cancer and lung cancer are drawing attention. According to industry sources, the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee (CDDC) is scheduled
- Company
- Hemophilia A drug 'Obizur' available at major hospitals
- by Eo, Yun-Ho Apr 28, 2025 05:54am
- Obizur, a treatment for acquired hemophilia A, is now available for prescription at general hospitals. According to industry sources, Takeda Korea's 'Obizur (susoctocog alfa),' a treatment for acquired hemophilia A (AHA) in adult patients, has passed drug committees (DC) of tertiary general hospitals, including Samsung Medical Center, Seo
- Company
- 'Early diagnosis·3 combo therapy·tolerance' for COPD Tx
- by Whang, byung-woo Apr 28, 2025 05:54am
- "With South Korea entering a super-aged society, the number of patients with chronic obstructive pulmonary disease (COPD) will continue to rise. As the population ages, early detection and treatment to prevent high-risk patients from worsening are critically important." At the end of last year, the Korean COPD treatment guidelines were revise
- Policy
- 'Social discussions needed for indication-based pricing'
- by Lee, Jeong-Hwan Apr 28, 2025 05:54am
- There have been calls for caution regarding the introduction of an “indication-based drug pricing system,” to improve patient access to multi-target anticancer drugs that treat various types of cancer. The concern is that if the insurance drug price for a specific disease among the multiple indications of an anticancer drug increases, t
- Company
- ‘Multiple-indication drugs improve survival rates’
- by Son, Hyung Min Apr 28, 2025 05:54am
- The Korean Research-based Pharmaceutical Industry Association (KRPIA) announced on the 24th that it successfully hosted a “Policy Forum on Eliminating Inequality in Innovative New Drugs and Improving Regulations” with Representative Mi-hwa Seo, Representative Byeong-Hoon So, Representative Yoon Kim, and Representative Jong-tae Jang (Health
- Company
- Janssen’s Rybrevant challenges the NSCLC throne
- by Whang, byung-woo Apr 25, 2025 05:59am
- The Rybrevant-Leclaza combination therapy, which has emerged as the standard of care in the field of lung cancer, is set to enter the market in earnest, backed by clinical data. With three additional indications for EGFR-mutated non-small cell lung cancer added this year, the company plans to leverage its leadership in the field of lung cance
- Policy
- ‘Should apply blended pricing and reimbursement rates’
- by Lee, Jeong-Hwan Apr 25, 2025 05:59am
- With multiple drugs with multiple indications, such as multi-targeted immunotherapy drugs, being approved in Korea, there have been claims that the introduction of an “indication-based drug pricing system” is necessary to improve patient access to treatment and ensure equity. In particular, the argument was made that ‘blended pricing,
- Policy
- "Will consider proposal for Indication-based pricing system"
- by Lee, Jeong-Hwan Apr 25, 2025 05:58am
- Regarding introducing an 'indication-based pricing system' aimed at improving patient access to medications, Lee Joongkyu, Director of the National Health Policy at the Ministry of Health and Welfare (MOHW), stated, "While it is still too early to announce when to implement the system, it is an opportune time to consider reviewing the propos
- Policy
- MFDS to improve essential drug designation standard
- by Lee, Hye-Kyung Apr 25, 2025 05:58am
- The Ministry of Food and Drug Safety will conduct a study to improve the standards for designating essential medicines. When the national essential medicine system was first implemented in 2017, the designation focused on government stockpiles, but there have been continuous calls to expand the list to include items that require stable su
