- Policy
- How much does new drug's R&D Investment cost?
- by Lee, Hye-Kyung Nov 26, 2019 07:11am
- The Organization for Economic Cooperation and Development (OECD) has presented monitoring of project activities to countries as part of future projects. Recent data suggests that a successful R & D cost estimate ranges from at least $ millions to $ 2.6 billion. Dahee Lee, a senior researcher at the Health Insurance Review and Assessmen
- Policy
- HIRA, "price transparency of RSA was reduced"
- by Lee, Hye-Kyung Nov 25, 2019 06:23pm
- The National Health Insurance Service (NHIS) plans to make reasonable efforts to implement the risk sharing agreement (RSA) in consideration of patient treatment access and insurance finance. The NHIS responded to Insoon Nam, a member of the National Assembly at a national audit about the plan to rationalize pharmaceutical expenditures, i
- Opinion
- [FOCUS]Government sophistication to generic regulations
- by Chon, Seung-Hyun Nov 25, 2019 06:21am
- A few years ago, a multinational pharmaceuticals announced “high quality” by launching generics in the domestic market. It is the aspiration to show good quality generics based on strict production management, product monitoring and quality assurance system that have long been recognized in the global market. At the time, the head of th
- Policy
- Surprise order by MFDS for all substance impurity risk test
- by Lee, Tak-Sun Nov 25, 2019 06:21am
- The Korean pharmaceutical industry is shook up as Ministry of Food and Drug Safety ordered companies to conduct tests on impurity contamination in all synthetic active pharmaceutical agents. Other foreign health authorities like European Medicines Agency (EMA) has released a new templates of carcinogen risk evaluation and confirmatory t
- Company
- The third JAK1 inhibitor,↑competition in Korea
- by Eo, Yun-Ho Nov 24, 2019 09:58pm
- It is the third rheumatoid arthritis drugs that is expectecd to enter domestic market. According to the industry, Abbie recently filed an application for permission to use 'Upadacitinib' for JAK inhibitors. Given the approval from the FDA in US on the 16th of last month, it is rapidly knocking on the Korean market. Abbie demonstrated t
- Policy
- NHIS, HIRA and NECA on joint reevaluation for listed drugs
- by Lee, Hye-Kyung Nov 24, 2019 09:58pm
- Drug Reimbursement Evaluation Committee (DREC) affiliated under Health Insurance Review and Assessment Service (HIRA) is to conduct reevaluation on already-listed high-cost drug items. When forming the seventh DREC, HIRA also established a ‘Post-marketing Drug Evaluation Subcommittee’ to be in charge of selecting insurance listed drug item
- Company
- Big5 hospitals adds Glead’s new HIV option Biktarvy
- by Eo, Yun-Ho Nov 24, 2019 09:58pm
- Glead’s new HIV combination drug, Biktarvy is landing its code on tertiary hospital’s prescription list. According to pharmaceutical industry source, Biktarvy has been passed by drug committee (DC) at the Big Five tertiary hospitals in Korea, including Seoul National University Hospital, Samsung Seoul Medical Center, Severance Hospita
- Policy
- Background of reimbursement standards enhancement of Avodart
- by Lee, Hye-Kyung Nov 24, 2019 09:57pm
- Starting this month, the 5α-reductase inhibitors (5ARI), reimburesement standards of Pinagren tablets 5mg (Finasteride) and Avodart 0.5mg (Dutasteride), which are used to treat prostate enlargement and hair loss, will be strengthened. The Ministry of Health and Welfare has decided to reimbursement benefits when it is administered to 'pos
- Company
- FDA Initiates biologics license of SB8, Samsung Bioepis
- by Chon, Seung-Hyun Nov 22, 2019 06:32am
- Samsung Bioepis announced on the 20th that FDA has initiated the approval and evaluation of the 'SB8' biosimilar of Avastin. In September, the FDA completed BLA for approval and entered into full-scale review for product approval Avastin, the original drug in Roche, has indications for metastatic colorectal cancer and non-small cell lung
- Company
- Localization of Korean pharmaceuticals in Vietnam is pouring
- by Nho, Byung Chul Nov 22, 2019 06:32am
- Recently, listed pharmaceutical companies are stepping up their efforts to localize Vietnam, which has been spotlighted as a Pharmerging market. Pharmaceutical companies investing in Vietnam include Chong Kun Dang (local branch), JW Pharmaceuticals(acquired Euvipharm), Korea United Pharm. Inc. (local plant), Ctcbio (joint plant),Shin Poong
