- Policy
- NHIS refuses to disclose immunotherapy reevaluation result
- by Moon, sung-ho Feb 15, 2021 06:16am
- Although the National Health Insurance Service (NHIS) has conducted a reevaluation on immunotherapies listed for reimbursement, the government agency decided to keep the outcome undisclosed. On the contrary, the Health Insurance Review and Assessment Service (HIRA) disclosed the outcome of a consignment research done with the same topic. The
- Policy
- Janssen, to close Hyangnam plant in Korea
- by Lee, Tak-Sun Feb 15, 2021 06:16am
- With the withdrawal of the Hyangnam factory this year, Janssen Korea is reorganizing its domestic product lineup of Tylenol and Ultracet The production of Tylenol 8 hours ER and Ultracet is undergoing a transition or shutdown procedure. According to the MFDS on the 8th, all Ultracet products, an analgesic combination drug containing Tra
- Policy
- Drug exempt from economic evaluation,cut to the lowest price
- by Lee, Hye-Kyung Feb 15, 2021 06:16am
- The NHIS continues to monitor foreign drug prices after signing and listing a drug price reduction contract linked to foreign prices for drugs exempt from economic evaluation in accordance with the drug price negotiation guidelines. In the past three years from 2018 to 2020, after 30 items of 14 pharmaceutical companies were listed on the lis
- Policy
- AstraZeneca vaccine authorized for use in Korea on Feb. 10
- by Lee, Tak-Sun Feb 15, 2021 06:16am
- The COVID-19 vaccine developed by AstraZeneca was finally approved by the South Korean health authority on Feb. 10. The approval is valid for the age group over 18, including elders older than 65. On Feb. 10, South Korea’s Ministry of Food and Drug Safety (MFDS) convened a Final Inspection Committee to make a decision on authorizing Ast
- Policy
- On-site judgment is important
- by Lee, Tak-Sun Feb 9, 2021 06:04am
- COVID-19 vaccine by AZ, along with CMA, recommended that those over 65 years of age should review it by the Vaccination Specialist Committee, the Central Pharmaceutical Affairs Review Committee of the MFDS said it was because on-site judgment was important. In a briefing held on the 5th, Chairman Il-Hwan Oh said, "Because the data on the
- Policy
- The Committee recommended AZ vaccine approval
- by Lee, Tak-Sun Feb 9, 2021 06:04am
- The Central Pharmaceutical Affairs Review Committee of the MFDS, which consulted on AstraZeneca's approval of the COVID-19 vaccine, recommended item approval, subject to the submission of ongoing clinical results. In addition, for vaccinations over 65 years of age, it was gathered that opinions should be made carefully in the matters of appr
- Policy
- Will the Committee allow AZ vaccine in the elderly?
- by Lee, Tak-Sun Feb 8, 2021 06:08am
- This is because the Central Pharmaceutical Affairs Review Committee, a specialized advisory body for the MFDS, determines the adequacy of the approval from 2pm. While it is expected that the Central Pharmaceutical Affairs Review Committee has decided on item approval, it is noteworthy how it will decide on the administration of the elder
- Policy
- Government-pharmaceutical organizations discuss measures
- by Lee, Jeong-Hwan Feb 8, 2021 06:07am
- The MOHW and medical groups discussed COVID-19 vaccination plan and comprehensive measures to strengthen health insurance non-reimbursement management. The operation plan of the Health and Medical Personnel Policy Deliberation Committee was also on the agenda of the meeting. On the 3rd, the MOHW (Minister Kwon Deok-cheol) held the 4th
- Policy
- Phase III fast track for Leclaza·Lynparza was approved
- by Lee, Jeong-Hwan Feb 5, 2021 05:54am
- While a bill was proposed to upgrade the fast track system in phase III to the pharmaceutical affairs law from the public announcement, 62 new drugs were counted to have taken the fast track so far. Most of domestic and overseas anticancer drugs such as Leclaza (Lasertinib) developed by Yuhan, AstraZeneca's Lynparza, Tagrisso (Osimertinib)
- Policy
- Special authorization requested for COVAX-Pfizer vaccine
- by Kim, Jung-Ju Feb 5, 2021 05:50am
- The South Korean disease control authority is requesting the health authority to grant a special approval on 117,000 doses of Pfizer vaccines to be supplied to the country by COVAX Facility. Under the supply agreement with COVAX Facility, the vaccines would be promptly introduced to South Korea for inoculation starting from this month.
