- Policy
- MFDS amends medical device permit renewal regulations
- by Lee, Hye-Kyung Sep 7, 2023 05:31am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) issued a pre-announcement of administration on September 6th regarding the amendment of the ‘Regulations on Renewal of Medical Device Manufacturing Permits.’ and will be receiving opinions until September 26th. The amendment contains changes such as requiring different data submi
- Policy
- What to expect from the upcoming 2-day HIRA DREC meeting
- by Lee, Tak-Sun Sep 7, 2023 05:31am
- The industry’s attention is focused on the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meeting that is being held for an unprecedented 2 days this month. The industry predicts that the 2-day term reflects the difficulty the committee will have in reaching a conclusion on the agendas set for
- Policy
- Daewoong withdraws its Herceptin biosimilar Ogivri from mkt
- by Lee, Hye-Kyung Sep 6, 2023 05:36am
- ‘Ogivri Inj. 150mg (trastuzumab),’ the third Herceptin biosimilar to be approved in Korea, is withdrawing from the Korean market. The Ministry of Food and Drug Safety announced on the 4th that Daewoong Pharmaceutical voluntarily withdrew its license for Ogivri in Korea. Ogivri was developed by the Ind
- Policy
- What about digital therapy devices awaiting approval
- by Lee, Hye-Kyung Sep 6, 2023 05:36am
- In addition to digital treatment devices for improving insomnia, the Ministry of Food and Drug Safety is expecting applications for licenses for digital treatment devices No. 3 and 4 aimed at improving symptoms in the fields of neurology and psychiatry, respiratory rehabilitation, visual disturbances, and tinnitus. Lee Young-rim, head of the
- Policy
- Reimb of HA eye drops will be restricted in KOR
- by Lee, Tak-Sun Sep 6, 2023 05:36am
- As a result of the government’s reimbursement reevaluations, patients will be unable to receive reimbursement when using hyaluronic acid eye drops for extrinsic diseases, and the amount of their use will also be restricted. The government has also been known to be discussing limiting reimbursement to 4 boxes per year. According to ind
- Policy
- Evaluating Tagrisso's primary benefit
- by Lee, Jeong-Hwan Sep 5, 2023 05:40am
- The Ministry of Health and Welfare announced that it is conducting a cost-effectiveness evaluation regarding the expansion of health insurance coverage for the first-line treatment of AstraZeneca's lung cancer drug Tagrisso. On the 4th, the Ministry of Health and Welfare responded as follows to a written question from People Power Party Rep.
- Policy
- Drug crime regulation,
- by Lee, Jeong-Hwan Sep 5, 2023 05:40am
- It is expected that a bill that would impose an obligation on doctors and pharmacists who prescribe and dispense drugs with a risk of misuse, such as narcotics, to check medication history through the Drug Safety Information System (DUR) will quickly pass the National Assembly. This is because a large number of drug-related crimes have occur
- Policy
- Why many choline alfoscerates accepted price cuts
- by Lee, Tak-Sun Sep 5, 2023 05:39am
- Companies are reluctant to self-manufacture their brain function enhancer choline alfoscerates despite price cuts. Only 20% of the companies decided to protect their drug price by switching to self-manufacture, and the prices of the others that opted to continue manufacturing through contract manufacture organizations (CMOs) were cut.
- Policy
- New GLP-1 RA stops reimb discussions in KOR
- by Lee, Tak-Sun Sep 4, 2023 05:04am
- The debut of a new GLP-1 analog used as an adjuvant to dietary and exercise therapy in diabetes patients has been postponed in Korea. This comes as a disappointment as only one single-agent drug is currently reimbursed in Korea, and the high global demand for the drugs has rendered domestic supply short. According to the Health Insur
- Policy
- Kanoa, the upper limit price was reduced further by PVA
- by Lee, Tak-Sun Sep 1, 2023 05:44am
- It was found that the upper limit of the choline alposerate formulation Kanoa Soft Cap sold by Ahnook Pharm has been reduced more with PVA (use-drug linkage agent) than the Kanoa Soft Capre-evaluation of the upper limit. There are a total of 18 items that have been re-evaluated and reduced by both the PVA this time, and among them, Kanoa
