- Policy
- A total of 3920 drugs have been lowered next year
- by Kim, Jung-Ju Dec 19, 2019 11:41pm
- It is expected that there will be a total of 3920 drugs whose insurance prices will fall from next year due to the real transaction price survey. Upper price limit is adjusted to 1.9% on average, and the price drops of popular blockbuster drugs are below the decimal point, but there are not many items that fall from 7% to 10%. According to th
- Policy
- Swiss companies to benefit from mutual recognition of GMP
- by Lee, Tak-Sun Dec 19, 2019 11:20pm
- A mutual recognition agreement of Good Manufacturing Practice (GMP) with Swiss pharmaceutical regulator Swissmedic would not only invigorate pharmaceutical trade between two countries, but also it is expected to be a meaningful step towards Korea earning recognition of international level of regulation. The mutual GMP recognition agreeme
- Policy
- Mandatory evaluation of MFDS when using all off label drugs
- by Lee, Jeong-Hwan Dec 19, 2019 06:35am
- A bill is piloted to require government assessments when using 'off-labeled drugs' in patients that go beyond the indications that have been proven in clinical trials, which are phases of drug marketing. Representative Sang-hee Kim of the National Assembly on Health and Welfare on the 18th proposed the partial revision of the Pharmaceutical
- Policy
- First Samsca generic submits approval application
- by Lee, Tak-Sun Dec 19, 2019 06:34am
- The first generic to follow Korea Otsuka Pharmaceutical’s Samsca (tolvaptan), indicated for treating euvolemic hyponatremia, has submitted an approval application to Korean Ministry of Food and Drug Safety (MFDS). The industry believes Myung In Pharma would be the one to grab the approval as it has been challenging the patent and develo
- Policy
- The MFDS plans to collect & test Metformin
- by Lee, Tak-Sun Dec 18, 2019 06:24am
- The Ministry of Food and Drug Safety (the Minister, Eui-Kyung Lee) has decided to collect and inspect commercial distribution items to investigate impurities on Metformin. As a result, the MFDS is preparing a test method with a goal within the year and is conducting a raw material system investigation for the preliminary safety management.
- Policy
- Why did MFDS release its Metformin self-investigation plan?
- by Lee, Tak-Sun Dec 17, 2019 07:20am
- The Ministry of Food and Drug Safety said on the 16th that it is directly investigating the drug 'Metformin', a drug that has been recovered and detected by carcinogen NDMA (N-nitrosodimethylamine) in Singapore. It was the first time that the MFDS announced its own investigation since the Singapore Health and Science Agency announced the
- Policy
- Exclusivity for Galvus’ generics applied Aug 2021
- by Lee, Tak-Sun Dec 13, 2019 11:00pm
- As expected, Ahn-Gook Pharmaceutical obtained the approval for exclusivity for generic product as Galvus (Vildagliptin), a diabetes treatment of DPP-4. The MFDS designated the priority sale items for Ahn-Gook Vildagliptin Tablet 50mg of Ahn-Gook Pharmaceutical and Ahn-Gook Newpharrm Vilagliptin Tablet 50mg of its subsidiary Ahn-Gook Newpha
- Policy
- Galvus SR developed by Alvogen, 100mg once daily
- by Lee, Tak-Sun Dec 13, 2019 06:34am
- Alvogen Korea is trying to differentiate itself from domestic competitors by developing Galvus SR tablets. The drug Alvogen develops is a sustained-release multi-layered tablet containing Vilagliptin, which is known to be taken once a day, unlike the original. The MFDS approved Alvogen Vildagliptin SR tablet’s clinical protocols on the 2
- Policy
- 'WHO PQ' for 3 domestic vaccines, including Skycellflu
- by Lee, Jeong-Hwan Dec 12, 2019 10:52pm
- Three domestic vaccines have secured international procurement bidding rights, obtaining WHO Prequalification (PQ). SK Bioscience's Sky Cellflu Multi inj, Sky Cellflu inj, and Sky Varicella inj are the main characters. On the 11th, the Ministry of Food and Drug Safety (The Minister, Eui-Kyung Lee) said, "The domestic vaccines passed the W
- Policy
- RSA opening more doors to new drugs, even to follow-ons
- by Kim, Jung-Ju Dec 12, 2019 06:31am
- More doors are to be opened for high-cost drugs to take the risk sharing agreement (RSA) track and to enhance patients’ access to treatments. The key change is to be made on the RSA eligibility, which was initially limited to first-in-class drug, to include follow-on drug. Accordingly, the RSA is expected to be available for highly unce
