- Policy
- Cold drugs subject to PVA will be adjusted
- by Lee, Tak-Sun Mar 31, 2023 06:08am
- The government is paying close attention to the correction plan for the price volume agreement (PVA) system that will be applied to respiratory drugs such as cold medicines whose usage has increased due to COVID-19. Therefore, the schedule the authorities had set to start PVA monitoring in April after finalizing the correction plan within
- Policy
- Overseas clinical trial drugs for therapeutic purposes
- by Lee, Hye-Kyung Mar 31, 2023 06:08am
- An amendment to the Pharmaceutical Affairs Act passed the plenary session of the National Assembly on the 30th, including permitting the use of investigational drugs overseas for therapeutic purposes, establishing a basis for prompt action against online illegal activities of drugs, and strengthening education and publicity on the labeling of
- Policy
- Started a demand survey for drugs participating in the pilot
- by Lee, Tak-Sun Mar 31, 2023 06:08am
- Due to the burden of simultaneous data submission, there are likely to be fewer participating drugs. The government started a demand survey for drugs to participate in the parallel trial project of 'Permission Evaluation Negotiation', which is being pursued rapid reimbursement. The project was planned to drastically shorten the registration
- Policy
- About 180 clinics without IRB used diagnostic drugs
- by Park,Yang-myeong Mar 30, 2023 05:42am
- Avastin and Decapeptyl, are drugs that allow the use of drugs beyond the scope of approval without the IRB. How much is it used in front-line medical institutions? About 230 macular degeneration treatment drugs Avastin and precocious puberty drug Decapeptyl injection were found to be using these drugs without IRB at 180 hospitals and clinics.
- Policy
- New Pompe disease drug Nexviazyme is approved in Korea
- by Lee, Hye-Kyung Mar 30, 2023 05:41am
- The long-term enzyme replacement therapy for Pompe disease, Nexviazyme Inj (avalglucosidase alfa-ngpt), has received marketing authorization in Korea. On the 29th, the Ministry of Food and Drug Safety (Minister Yu-Kyung Oh) announced that it had approved Sanofi-Aventis Korea’s Nexviazyme, a treatment for a rare condition called Pompe dis
- Policy
- Obizur will be evaluated for reimbursement upon approval
- by Lee, Tak-Sun Mar 30, 2023 05:41am
- Obizur, a treatment for acquired hemophilia A for adults, approved on the 20th, immediately began a benefit evaluation. This drug is attracting attention as it is the first treatment to replace blood coagulation factor 8 with an indication for acquired hemophilia A. According to the industry on the 29th, the HIRA received an application fo
- Policy
- Govt seeks to improve the drug price reduction system
- by Lee, Tak-Sun Mar 29, 2023 06:02am
- The Korean government will be working together with the pharmaceutical industry to come up with plans to improve the price reduction system that discounts the actual transaction price of drugs. The Health Insurance Review and Assessment Service plans to hold a roundtable meeting with the pharmaceutical industry to improve the actual dru
- Policy
- 87.5% of anticancer/rare drugs, evaluated as drugs w/o PE
- by Lee, Tak-Sun Mar 29, 2023 06:01am
- As the PE drug standard expands, the HIRA is seeking a reasonable management plan. This year, we plan to improve and supplement the PE system by deriving detailed plans through research services. Yoo Mi-young, head of the Pharmaceutical Management Office at the Health Insurance Review and Assessment Service, explained this at a meeting with t
- Policy
- Erleada is listed
- by Lee, Tak-Sun Mar 28, 2023 05:56am
- Janssen Korea, which succeeded in listing Erleada, a new prostate cancer treatment drug, voluntarily lowers the upper limit on Zytiga, an existing prostate cancer treatment drug. The industry believes that another so-called 'trade-off' case appeared last year when MSD lowered the upper limit on its drug while expanding reimbursement for the i
- Policy
- Jeil Pharmaceutical discontinued Actos co-promotion
- by Lee, Tak-Sun Mar 27, 2023 05:56am
- Jeil, which has already launched sales of the generic drug Actozone 15mg and the combination drug Actozonemet 15/850mg from 4Q last year, is expected to launch Actozon 30mg in the reimbursement market in April. According to the industry on the 26th, Actozon 30mg will be listed at the upper limit of 940 won from April 1st. There are still fewe
