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Policy
Taiwanese PharmaEssentia got a business license
by
Lee, Tak-Sun
Nov 5, 2021 05:24am
PharmaEssentia, a Korean subsidiary of PharmaEssentia, a Taiwanese pharmaceutical company, has obtained a drug business license. The first CEO of PharmaEssentia in Korea is Haksun Moon, former representative of Novartis Korea. The MFDS granted PharmaEssentia Korea a drug business license as of the 4th. The first factory is located on the 1
Policy
Gov needs to maintain patient benefits to the public
by
Lee, Jeong-Hwan
Nov 5, 2021 05:23am
Starting next year, the Korea Organization For Patient Group expressed regret to the MOHW and the HIRA, which triggered anxiety and confusion among cancer patients by announcing plans to exclude second-tier anticancer drugs from the coverage. The Korea Organization For Patient Group urged the MOHW and the HIRA to give confidence in ensurin
Policy
The HIRA proceeds to improve the mediation system
by
Lee, Hye-Kyung
Nov 4, 2021 05:56am
The MOHW requests the promotion of research services for effective system operation. Improvement of the adjustment application system will be carried out to raise the upper limit of -reimbursed drugs. The HIRA recently made an open bid for a "request for research proposal on how to improve the drug adjustment application system" and announced
Policy
MFDS to support Phase III trials of domestic COVID-19 Txs
by
Lee, Tak-Sun
Nov 4, 2021 05:56am
The Ministry of Food and Drug Safety has been supporting domestic companies that have entered Phase III trials for their domestic COVID-19 treatments through its ¡®Development-focused Support Council.' The three items currently approved for Phase III trials and supported by the Support Council are: Chong Kun Dang¡¯s ¡®Nafabeltan (nafamos
Policy
NA asks NHIS to introduce the reference pricing system
by
Lee, Hye-Kyung
Nov 4, 2021 05:55am
The National Assembly raised the opinion that a reference pricing system should be introduced to induce price competition between generic drugs and encourage the use of cheaper generics. NA member Youngseok Seo of the Democratic Party of Korea inquired on introducing the reference pricing system to normalize the generic market and reduce
Policy
Refund RSA may be set higher than the lowest price
by
Lee, Jeong-Hwan
Nov 4, 2021 05:55am
The HIRA said that the cost-effectiveness evaluation criteria for omitted drugs that submit economic evaluation data are less than 80% of the lowest A7 adjustment price. It also explained that the economical evaluation drug can be integrated into a risk-sharing system (RSA), which can set the indicator price higher than the lowest A7 price in
Policy
Finding a system that suppresses the use of expensive drugs
by
Kim, Jung-Ju
Nov 4, 2021 05:55am
The HIRA said it will seek a system to prevent indiscriminate use of expensive drugs and manage expensive products that have already been registered. The HIRA also said it would make it mandatory to inspect the use of DUR systems for safe use. The HIRA submitted a recent written answer to Seo Young-seok, a member of the Democratic Party o
Policy
HIRA deletes GDP phrase but maintains current ICER threshold
by
Lee, Hye-Kyung
Nov 3, 2021 05:47am
The industry has requested an explanation on why the Health Insurance Review and Assessment Service deleted the ¡®reference to per GDP capita¡¯ phrase in its ICER threshold regulations. On the 23rd, HIRA disclosed the ¡®Detailed Evaluation Criteria for drugs subject to negotiation such as new drugs, etc.,' and changed the ICER threshold crite
Policy
The new system doesn't stop benefits for anticancer drugs
by
Lee, Jeong-Hwan
Nov 3, 2021 05:47am
The MOHW promised to operate a system that does not cause damage to patients due to the suspension of high-priced anticancer drug benefits due to the expansion of the new comprehensive insurance system. The plan is to review and operate measures to ensure continuity of treatment for existing patients taking expensive anticancer drugs such as
Policy
The number of licenses for Rx drugs in October exceeded 100
by
Lee, Tak-Sun
Nov 3, 2021 05:46am
The number of monthly permits increased again as the generic release of AstraZeneca's diabetes combination drug "Xigduo XR (Metformin+Dapagliflozin Propanediol Hydrate)" first appeared in October. As many as 31 generics for Xigduo XR were approved in October, all of which are consignment items manufactured by Richwood Trading Company. It
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