- Policy
- Welfare committee passed a set of three bills about COVID-19
- by Lee, Jeong-Hwan Feb 24, 2020 06:25am
- The parliamentary welfare committee approved the three measures about COVID-19 at the plenary session on the 20th morning Three bills about COVID-19 were thus reviewed by the Legislation-Judiciary Committee. After passing through the judiciary committee, the final plenary session must be resolved before the final promulgation can be mad
- Policy
- Full inspection on BTX manufacturers and vaccine distributor
- by Lee, Tak-Sun Feb 24, 2020 06:23am
- Korea's Ministry of Food and Drug Safety (MDFS) plans to pin-point inspect 'botulinum toxin manufacturer' and 'chicken pox vaccine cold chain.' The focused inspection on biopharmaceutical would be completed by the first quarter. MFDS posted the 'Biopharmaceutical Manufacturer and Distributor Management Master Plan 2020 (biopharmaceut
- Policy
- NHIS fully inspects 1479 nursing facilities for COVID-19
- by Lee, Hye-Kyung Feb 21, 2020 06:36am
- National Health Insurance Service (NHIS, President Kim Yong Ik) has announced a plan to inspect all 1,479 nursing facilities and long-term care institutes to prevent spreading of COVID-19. From Feb. 17 to 18, NHIS has inspected all nursing facilities related to status of inpatient with pneumonia from unknown cause, staff and nurse with t
- Policy
- Stivarga renews RSA and Azilect lowers pricing by 30%
- by Kim, Jung-Ju Feb 21, 2020 06:36am
- By renewing an expiring risk sharing agreement (RSA) with National Health Insurance Service (NHIS), Bayer Korea has decided to lower the maximum reimbursed price for metastatic colorectal cancer and gastrointestinal stromal tumor (GIST) treatment Stivarga 40 mg tablet (regorafenib) by 7 percent. And the health regulator has authorized pricin
- Policy
- Generic drug for Lipiodol was approved
- by Lee, Tak-Sun Feb 21, 2020 06:35am
- The generic drug of Lipiodol, a special contrast agent which was controversial due to a demand for price increase by the seller, received an item license. Lipiodol may not be able to treat patients in the event of a supply disruption, since there have been no drugs of the same composition so far. With the approval of the generic drug, it i
- Policy
- Hospitals & pharmacies will get COVID-19 benefit early
- by Lee, Jeong-Hwan Feb 20, 2020 10:41pm
- The Minister of Health and Welfare, Neung Hoo Park, noticed the implementation of an early payment within 10 days after the application for the medical expenses paid by hospitals, clinics and pharmacies which were damaged or involved in COVID-19. It will also suspend various investigations and examinations for medical institutions for a ce
- Policy
- MFDS reveals detailed clinical trial inspection plan
- by Lee, Tak-Sun Feb 20, 2020 06:35am
- Korea’s Ministry of Food and Drug Safety (MFDS) plans to conduct extensive inspection on clinical trial regarding pharmaceutical approval. The subjects are new drugs and drugs required to submit evidential data. Accordingly, pharmaceutical companies, CRO, and healthcare institutes would be investigated by Clinical Trial Management Division
- Policy
- If the MFDS followed the EMA instead of the FDA for Belviq
- by Lee, Tak-Sun Feb 19, 2020 06:33am
- At the time of approving Belviq, banned by the MFDS on the 14th, it would be regrettable that it had not been approved in accordance with the European EMA's decision. The European EMA disagreed with the approval due to side effects from animal testing, and the developer voluntarily withdrew the application. The US FDA, on the other ha
- Policy
- MOHW to require reimbursement negotiation for generic
- by Kim, Jung-Ju Feb 19, 2020 06:32am
- Even generic drugs, reimbursed pricing decided according to set formula, would have to negotiate with the insurer about the insurance benefit. The government is aiming to establish legal basis to prevent companies evading pricing reduction by listing the same drug as another, and also to require post-management. Basically, the revisio
- Policy
- NSCLC targeted therapy Vizimpro approved in Korea
- by Lee, Tak-Sun Feb 18, 2020 06:35am
- Pfizer Pharmaceutical Korea’s non-small cell lung cancer (NSCLC) targeted therapy Vizimpro has been approved to market in Korea. The treatment is a second-generation targeted therapy like Boehringer Ingelheim’s Giotrif. On Feb. 14, Ministry of Food and Drug Safety (MFDS) has approved Pfizer Pharmaceutical Korea’s three Vizimpro tablet
