- Opinion
- [Reporter's View] GMP standards for sterile products
- by Lee, Hye-Kyung Jun 17, 2025 05:58am
- The Ministry of Food and Drug Safety (MFDS) is devising measures to reduce the burden on the pharmaceutical industry ahead of the implementation of the 'Revised PIC/S Good Manufacturing Practices (GMP) Guide for Sterile Medicinal Products (guidelines on manufacturing and quality control of medicines)' in December. Following the administrative
- Opinion
- [Reporter's View] Fostering BD talent requires tech·strateg
- by Whang, byung-woo Jun 12, 2025 06:04am
- Recently, the role of business development (BD) in the pharmaceutical and biotech industry has been rapidly advancing. Previously regarded simply as a sales task, BD changed to one of the core strategic teams that oversees the success of new drug development. BD is responsible for key discovery and execution of various opportunities for n
- Opinion
- [Reporter's View] Biotech policy must be consistent
- by Jun 4, 2025 06:17am
- What's the most critical factor in corporate management? It's challenging to pinpoint whether it's capital, talent, or technology. However, for all these elements to function, a prerequisite must be established: predictability. A company must be able to foresee the future to invest and endure risks to recruit and conduct R&D. South Korea
- Opinion
- [Reporter's View] Addressing drug shortage, healthcare
- by Lee, Jeong-Hwan May 30, 2025 05:57am
- Ahead of Korea's early presidential election, scheduled for June 3, leading candidates have prioritized pledges to strengthen government support for essential medicines·address drug shortages. Lee Jae-myung, the candidate for the Democratic Party of Korea, included the resolution of a supply shortage of essential medicines in his top 10
- Opinion
- [Reporter’s View] Reimbursing the only RET-targeted therapy
- by Eo, Yun-Ho May 29, 2025 05:52am
- News of a new drug failing to be listed for insurance reimbursement always upsets patients. The blow is even harder when it is the only treatment option available. Such was the case in 2023 when the National Health Insurance Service and Lilly failed to reach an agreement on the price of the RET-targeted anticancer drug Retevmo (selpercati
- Opinion
- [Reporter's View] 'Samsung Epis' as independent firm
- by Whang, byung-woo May 23, 2025 05:51am
- Samsung Biologics officially announced on May 22 that its shareholders determined to conduct a spinoff of Samsung Bioepis and establish 'Samsung Epis Holdings.' The business independence of Samsung Bioepis, which expanded its focus on biosimilars, was conducted earlier than anticipated. It has been two years since Samsung Biologics acquire
- 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
