- Policy
- Remdesivir's special import was decided
- by Lee, Tak-Sun Jun 5, 2020 06:10am
- The special import of Gilead’s Remdesivir was decided. It will be used in severely hospitalized patients infected with the COVID-19. The MFDS (Minister Lee Eui-kyung) decided to import special cases for Remdesivir, which is being developed as a treatment for COVID-19, and accordingly, the KCDC (Director Eun-Kyung Jung), announced on the 3
- Policy
- COVID-19 vaccine by Inovio was first approved in Korea
- by Lee, Tak-Sun Jun 5, 2020 06:09am
- COVID-19 vaccine is the first clinical trial approved in Korea. It is a vaccine candidate developed by Inovio of the United States and is conducted by theInternational Vaccine Institute (IVI). On the 2nd, the MFDS approved phase I/IIa of IN0-4800, a candidate for COVID-19 vaccine, applied by the IVI. In clinical trials, the safety, tole
- Policy
- Permission is increasing prior to the end of PMS
- by Lee, Tak-Sun Jun 4, 2020 10:41pm
- Even before the end of PMS (Post marketing surveillance), a lot of new items have been approved through a contract production contract with the original company. Since PMS system in Korea is also provided with the data protection function of the original drug, it is possible to apply for a license for the same ingredient after PMS expires.
- Policy
- Labeling will be promoted on product packaging
- by Lee, Tak-Sun Jun 4, 2020 06:14am
- In the future, it is expected that pharmaceutical companies carrying out bioequivalence tests will be separately labeled on generic drug packaging. In addition, policy initiatives are being undertaken to strengthen the global competitiveness of generic drugs, such as finding ways to disclose generic companies on a manufactory basis. The MF
- Policy
- The MFDS designated Mobocertinib as an orphan drug
- by Lee, Tak-Sun Jun 3, 2020 06:25am
- The MFDS (Minister Eui-kyung Lee) announced that Mobocertinib was newly designated as an orphan drug, and it announced on June 1 that target diseases were added for three types, such as Ipilimumab, designated as an orphan drug. An orphan drug is a drug that is used for the purpose of diagnosing or treating a rare disease, a drug that has
- Policy
- Handok takes over Eisai’s Aricept license from Daewoong
- by Lee, Tak-Sun Jun 3, 2020 06:25am
- The Korean market license for the dementia treatment market leader Aricept (donepezil) has been transferred from Daewoong Pharmaceutical to Handok. Except for a few items, Handok is to manufacture the treatment in Korea. Daewoong Pharmaceutical has been importing active ingredient from a Japanese-based pharmaceutical company Eisai that
- Policy
- MFDS & FDA have different NDMA’s follow-up measures
- by Lee, Jeong-Hwan Jun 2, 2020 09:13pm
- The domestic pharmaceutical industry has pointed out that the MFDS and the US Food and Drug Administration (FDA) have made unusually different follow-up measures over NDMA detection Metformin. The MFDS caused an immediate and irreversible damage to pharmaceutical companies by disposing of manufacturing and sales prohibition along with the ful
- Policy
- Janssen to import Ultracet as Hyangnam factory closes
- by Lee, Tak-Sun Jun 2, 2020 06:09am
- As Janssen Korea is closing down its Hyangnam factory next year, the locally manufactured pain reliever Ultracet fast-acting tablet (acetaminophen plus tramadol hydrochloride) would be imported, instead. However, the extended release tablet form of the drug, developed in Korea, would be manufactured by Handok. A pharmaceutical industr
- Policy
- The emergency introduction of Remdesivir was confirmed
- by Lee, Tak-Sun Jun 2, 2020 06:09am
- The government urgently introduced Gilead's 'Remdesivir' as a cure for COVID-19. Accordingly, the MFDS is planning to go through a special import procedure. Eun-kyung Jung, Head of the Central Disease Control Headquarters, said at the regular briefing on the 29th that the Central Clinical Committee on 28th suggested the need for the introd
- Policy
- Pfizer's non-steroidal eczema, under phase III in Korea
- by Lee, Tak-Sun Jun 1, 2020 06:20am
- A non-steroidal ointment that can be used for eczema in children is under clinical trial for domestic introduction. Pfizer's Crisaborole is a drug sold in the United States under the name of 'Eucrisa' after it was approved by the US in 2016. The MFDS approved a multinational clinical trial phase III for Pfizer’s Crisaborole on the 29th of
