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Policy
Winner of pricing suits will be compensated for damages
by
Kim, Jung-Ju
Nov 26, 2021 05:54am
The countless litigations between government and companies regarding reimbursements such as drug price cuts or reduced scope of reimbursement are causing wasteful losses to both parties. On this, the government and the National Assembly have been proposing various solutions to prevent excessive stay of executions. The NA has proposed a
Policy
Cost bearer in debate ahead recall of some losartan products
by
Lee, Tak-Sun
Nov 26, 2021 05:53am
The MFDS has mentioned ¡®re-prescribing or re-dispensing' some items at meetings with medical, pharmacist, and pharmaceutical associations while discussing measures to recall some of the antihypertensive ¡®losartan¡¯ products that were found to contain azido impurities during inspections. The re-prescribing or re-dispensing measures are p
Policy
All agreed to the legislation of the CSO reporting system
by
Lee, Jeong-Hwan
Nov 26, 2021 05:53am
The MOHW, as well as KPBMA, KRPIA, and Korean Pharmaceutical Association, approved the mandatory government and local government reporting bill by CSO. Except for the opinion that the regulations related to the CSO reporting system should be tightened compared to the legislation pending in the National Assembly, no organizations opposed it.
Policy
Losartan, which has a high proportion of consignment
by
Lee, Tak-Sun
Nov 25, 2021 05:55am
Concerns are growing as the proportion of consignment production is high in HBP treatment "Losartan" formulation, which is known to have excess Azido-based impurities. If it appears as an impurity problem at the raw material stage, there is a possibility that many pharmaceutical companies tied up with consignment will start collecting product
Policy
Discussions began on the scope of Mifegymiso license
by
Lee, Tak-Sun
Nov 24, 2021 05:53am
An expert meeting was held on the 24th, and the review was conducted regardless of the revision of the criminal law. The MFDS, which is reviewing the product license of Mifegymiso, a drug for abortion, has begun a discussion process on the specific scope of use rights. It is a policy to decide through collecting opinions from all walks of lif
Policy
Betmiga PR prices fluctuated 3 times Between 15 days
by
Kim, Jung-Ju
Nov 24, 2021 05:53am
It is a drug with a lot of stories. Betmiga PR (Mirabegron) of Astellas Pharmaceutical of Korea, which is in a lawsuit with the government to cancel the drug price drop, is a drug with a lot of price fluctuations. The drug has repeatedly filed lawsuits against the government's drug price cut, returning, cutting and raising drug prices as t
Policy
MFDS cautious on waiving bridging trial for abortion pill
by
Choi-sun
Nov 24, 2021 05:53am
The Ministry of Food and Drug Safety, which had been accelerating the approval of the induced abortion pill Mifegymiso (misoprosto + mifepristone), has taken a step back in response to the caution urged by the National Assembly among others at the NA audit. Despite being advised to waiver the bridging study by the Central Pharmaceutical Affai
Policy
Nam In-soon's drug price recovery bill excludes rebates
by
Lee, Jeong-Hwan
Nov 23, 2021 05:55am
The "Return and refund of suspension of execution of drug prices" bill proposed by Rep. Nam In-soon of the Democratic Party of Korea varies in scope of application to benefits deletion, suspension of benefits, and drug price reduction due to revaluation of starting drugs. However, Rep. Nam In-soon's bill does not include the disposition of dr
Policy
Brilinta¡¯s price cut 30%, Nexavar¡¯s premium stays 1 year
by
Kim, Jung-Ju
Nov 23, 2021 05:54am
The insurance price of AstraZeneca Korea¡¯s Brilinta tab. 90mg (ticagrelor) and Daxas tab. 500¥ìg (roflumilast) will be reduced by 30% through the government¡¯s ex-officio adjustment starting next month. On the other hand, the price of Bayer Korea¡¯s Nexavar 200mg (sorafenib tosylate) will be maintained at its level for one more year. The pri
Policy
Benefit for 46 generics for Eliquis will be kicked out
by
Kim, Jung-Ju
Nov 22, 2021 05:52am
BMS won the patent dispute between BMS' Eliquis (Apixaban) and it's generics, which had a patent dispute between companies due to generics released before the patent expired. Dozens of generics have been forced to withdraw their benefits. Generics will be legally removed from the list immediately on the 1st of next month due to the establishment
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