- Policy
- Detailed screening for α -GPC begins in earnest next year
- by Moon, sung-ho Dec 7, 2021 05:57am
- Tensions are rising as the government announces the review of the revised supplementary budget bill starting next year amid deepening concerns among pharmaceutical companies over the issue of Choline Alfoscerate. According to the pharmaceutical industry and the medical community on the 1st, it has been confirmed that the MOHW has decided to s
- Policy
- The original patent's negotiation period will be reduced
- by Kim, Jung-Ju Dec 7, 2021 05:57am
- The period of ex officio adjustment drug price negotiations for the original drug that expires patents collectively cut drug prices will be reduced to one-third. It is aimed at improving cases of health insurance financial leaks by abusing the prescribed negotiation period as much as possible when the legal drug price cut rate is set. The MOH
- Policy
- KB Pharm's generic for Vildagliptin nitrate will be approved
- by Lee, Tak-Sun Dec 6, 2021 05:54am
- The post-inflammatory drugs of the diabetes treatment Galvusmet (Vildaglipin-Metformin Hydrochloride), which the Supreme Court ruled invalidating part of its extended duration, are appearing one after another. These items will be able to be released early in January next year if some of their duration is confirmed to be invalid. On the 30t
- Policy
- Asciminib's domestic approval is at a quick step
- by Lee, Tak-Sun Dec 6, 2021 05:53am
- Novartis' Asciminib, which is attracting attention as a fourth-generation targeted anticancer drug in the chronic leukemia treatment market, is also speeding up domestic permits. The drug, which was approved by the U.S. FDA last month, has recently been approved for four clinical plans in Korea alone, boosting the analysis that it is acce
- Policy
- Companies in a dilemma over who bears losartan recall cost
- by Lee, Tak-Sun Dec 3, 2021 05:55am
- Pharmaceutical companies are unsatisfied with the health authorities’ request for companies to fully bear the cost of exchanging ‘losartan’ products that were found to contain azido impurities. While many companies have submitted the ‘cost-bearing letter of commitment,’ the companies have been left with a bitter aftertaste, due to
- Policy
- MFDS reviews Pfizer COVID-19 vaccine used without dilution
- by Lee, Tak-Sun Dec 2, 2021 05:54am
- On the 30th, the Ministry of Food and Drug Safety had announced that it had started reviewing the approval of Pfizer’s COVID-19 vaccine that does not require dilution &8211; ‘Comirnaty inj. 0.1㎎/㎖ (registered name)’ &8211; after the company applied for the authorization of its import product license. The product contains the same a
- Policy
- Did Mooncare truly reinforce coverage for rare diseases?
- by Eo, Yun-Ho Dec 1, 2021 05:57am
- The voice requesting expanded coverage for patients with rare diseases had been exceptionally high this year in the 4th year of Mooncare. Starting with NA discussions held to enhance coverage of innovative new drugs for rare genetic disorders in May by the NA Health and Welfare Committee member Sunwoo Kang, NA members Byungwon Kang, Woni Kim,
- Policy
- 30 new drug items reimbursed or extended coverage this year
- by Kim, Jung-Ju Nov 30, 2021 05:52am
- 30 new drugs were newly listed on the reimbursement list or extended reimbursement standards from January this year to this month. Among these, 25 were newly listed new drugs, and 5 were already-listed new drugs that have extended their scope of reimbursement and increased coverage. The reinforced coverage of new drugs this year benefited on
- Policy
- Review period & material improved for COVID-19 Txs, etc.
- by Lee, Jeong-Hwan Nov 29, 2021 05:58am
- The government will lead the improvement of administrative effectiveness and predictability by preparing specific standards on the review period and scope of materials submitted for the marketing approval of pharmaceuticals. The measure was made as means for the government to preemptively respond to the expedited approval of new drugs, anti
- Policy
- A new pre-approval system for Ultomiris was established
- by Lee, Hye-Kyung Nov 29, 2021 05:58am
- The pre-approval application system for Ultomiris, a treatment for night hemoglobin (PNH) in Handok, has just been established. The HIRA recently established a new Ultomiris pre-approval application system in the nursing institution business portal. The application for pre-approval of Ultomiris is in the same position as Soliris, which is previo
