- Policy
- The NHIS sequentially began managing the entire drug cycle
- by Lee, Hye-Kyung Apr 8, 2021 05:54am
- The NHIS prepares management measures such as treatment effect and cost effectiveness after registration. The NHIS sequentially began managing the entire drug cycle. The NHIS began recruiting external researchers to prepare post-evaluation plans based on actual clinical data after listing drugs exempted from PE Study. This research service is
- Policy
- 1.25 million doses of Pfizer vaccine were released
- by Lee, Tak-Sun Apr 7, 2021 06:01am
- It was found that 1.25 million doses of Pfizer vaccine, which had been individually contracted so far, received lot release from the MFDS. Following 1 million doses arriving in March, an additional 250,000 doses received lot release from the government in April, and vaccinations started to the general public. According to the MFDS on
- Policy
- AZ vaccine was approved in the second week of February
- by Lee, Tak-Sun Apr 7, 2021 06:00am
- The government said it expects the AstraZeneca COVID-19 vaccine to be approved in the second week of February. In the third week of February, the lot release is completed and the vaccination is started immediately. The MOHW, the MFDS, and the KCDA made such a statement at the President's Business Report (video conference) held on the 25th. Ac
- Policy
- Dongkoo is targeting the market as a vendor.
- by Lee, Tak-Sun Apr 6, 2021 06:08am
- In January, Dongkoo started as a vendor of generic for Atozet (Atorvastatin·Ezetimibe), a licensed hyperlipidemia complex, and started targeting the market in April. Dongkoo is the most entrusted company of generic for Atozet. However, generics for Atozet are scheduled to release in May, but Dongkoo is going to enter the market a month a
- Policy
- The clean reporting center will be opened
- by Lee, Tak-Sun Apr 5, 2021 05:53am
- The MFDS opened the Clean Report Center for Drug Manufacturing and Quality Illegal Activities in order to revitalize public interest reporting after Binex drug manufacturing incident. The center operates anonymously to increase the reporting rate. The MFDS announced on the 1st that it has opened the Clean Report Center for Drug Manufacturi
- Policy
- Janssen vaccine was confirmed to maintain an immune response
- by Lee, Tak-Sun Apr 5, 2021 05:50am
- The COVID-19 vaccine license verification advisory group composed of external experts recognized the preventive effect of Janssen's COVID-19 vaccine. Janssen vaccine was confirmed that the immune response was maintained for up to 12 weeks with only one administration. The COVID-19 vaccine safety and effectiveness verification advisory grou
- Policy
- Are there less than 20 licensed generic drugs?
- by Lee, Tak-Sun Apr 2, 2021 06:05am
- The pharmaceutical industry is looking for generics with less than 20 identical ingredients/same content due to the effect of stepped drug prices. This is because there is a large difference in drug price depending on whether there are more than 20 or less than 20 outsourced generics permitted to use bioequivalence test data. The recent in
- Policy
- Levitra was withdrawn from the Korean market after 20 years
- by Lee, Tak-Sun Apr 2, 2021 06:05am
- Levitra, which Bayer launched on the Korean market for erectile dysfunction drugs, withdrew completely on the 1st. It was withdrawn due to expiration of the validity period because Bayer Korea did not renew the license. Only Kyongbo Vardenafil HCl of Kyongbo, a subsidiary of Chong Kun Dang, remains in the active ingredient containing Varden
- Policy
- Addpharma, entering phase 3 of low-dose Dutasteride
- by Lee, Tak-Sun Apr 1, 2021 06:06am
- Addpharma, a subsidiary of Yuhan's improved drug development, has entered phase 3 clinical trials of low-dose tablets of Dutasteride (Avodart, GSK), a hair loss treatment. Currently, Dutasteride is already on the market, but the value of Addpharma's developed products is high as there is no low dose product. The MFDS approved Addpharm
- Policy
- Baricitinib, Heparin, & NOAC were added as COVID-19 benefits
- by Lee, Jeong-Hwan Apr 1, 2021 06:05am
- Benefits are recognized when Baricitinib is co-administered with Remdesivir for the treatment of COVID-19. Low-molecular-weight heparin and new anticoagulant (NOAC) are also newly added as COVID-19 benefits. Lopinavir / Ritonavir (combination therapy), Hydroxychloroquine, and Ribavirin are eliminated from drugs covered by COVID-19. On the
