- Policy
- Implementation of projects linked to permission evaluation
- by Kim, Jung-Ju Dec 5, 2022 05:53am
- The government will conduct a pilot project of the "Permission Evaluation Negotiation Linkage System" in the first half of next year, which will simultaneously carry out three tracks of the drug market-wage hurdles, including the Ministry of Food and Drug Safety's item license safety and efficacy evaluation and the NHIS drug price negotiation
- Policy
- MOHW “reasonably decide on using A9 countries as reference"
- by Kim, Jung-Ju Dec 5, 2022 05:53am
- i1 Regarding criticism from the industry on how the systemic reform of adding Australia and Canada to the existing A7 countries as drug price reference countries that are used for new drug insurance reimbursement evaluations, the government said it would make a reasonable decision after collecting industry and expert opinion. The Ministry o
- Policy
- The safety & efficacy evaluation of Jemperili was terminated
- by Lee, Hye-Kyung Dec 5, 2022 05:53am
- Authorization of domestic items for GlaxoSmithKline's immuno-cancer drug Jemperili is imminent. According to the pharmaceutical industry on the 1st, the Ministry of Food and Drug Safety recently ended Jemperili's safety and efficiency evaluation. As the safety and efficacy evaluation has been completed, permission will be obtained soon if the
- Policy
- Domestic new drug No. 36 Envlo has been approved
- by Lee, Hye-Kyung Dec 5, 2022 05:53am
- Envlo 0.3mg, the 36th domestic development new drug, has been approved in Korea. The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced on the 30th that it has approved Daewoong Pharmaceutical's Envlo to improve blood sugar control in patients with type 2 diabetes. Envlo is an adjunct to diet and exercise therapy administer
- Policy
- Roche’s Lunsumio receives 1st GIFT designation in Korea
- by Lee, Hye-Kyung Dec 1, 2022 05:46am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced that it had designated Roche Korea’s ‘Lunsumio Inj (mosunetuzumab)’ as the first product subject to the Global Innovative product on Fast Track (GIFT) program it has been operating since September to support the development of innovative medical products in Korea.
- Policy
- The price of Donepezil 5mg fell below 500 won
- by Lee, Tak-Sun Dec 1, 2022 05:46am
- Donepezil, which is most commonly used to treat dementia, fell to less than 500 won for 5mg due to the step-type drug price implemented in July 2020. The drug prices refer to 85% of the lowest price of the upper limit of the same product registered if more than 20 products are registered. According to industries on the 29th, Donepezil HCl app
- Policy
- Pediatric drugs eligible for PE exemptions from January
- by Kim, Jung-Ju Dec 1, 2022 05:46am
- The government expects the ‘Measures to Improve Patient Access and Reinforce Reimbursement Management for High-Priced Severe Disease Treatments’ that gained industry attention for increasing the scope of use of the pharmacoeconomic evaluation exemption system (PE exemption system) will be applied to drugs that apply for reimbursement in J
- Policy
- First Forxiga follow-on Dapapro listed at KRW 684
- by Lee, Tak-Sun Nov 29, 2022 05:54am
- The first follow-on of the antidiabetic SGLT-2 inhibitor ‘Forxiga Tab (dapagliflozin, AstraZeneca)’ will be listed at ‘Dapapro Tab’ with reimbursement at KRW 684 on December 1. The price has been set at 90% of the original due to premium pricing as a data submission drug due to salt modification, etc. Dapapro Tab succeeded in avoid
- Policy
- Avastin biosimilar will be reimbursed starting next month
- by Lee, Tak-Sun Nov 29, 2022 05:53am
- Celltrion's Avastin biosimilar Vegzelma will be listed on the 1st of next month. As a result, Roche, which owns the original Avastin, has joined Alvogen Korea, a biosimilar company, Samsung Bioepis, and Celltrion, making the market competition a four-way race. According to industries on the 25th, Celltrion Vegzelma's 0.1g and 0.4g will be
- Policy
- Actilyse's price to rise 15% from next month
- by Kim, Jung-Ju Nov 28, 2022 05:50am
- The price of Boehringer Ingelheim’s acute myocardial infarction treatment Actilyse Inj. (alteplase) will rise 15% from next month after applying for drug pricing adjustments. Aju Pharm’s acute back pain reliever (aceclofenac, eperisone hydrochloride) will newly receive a 10% premium for 1 year. Also, the 30.4% premium pricing for Hanmi Phar
