- Policy
- Promote legislation to include the shingles vaccine in NIP
- by Lee, Jeong-Hwan Aug 21, 2020 06:26am
- A bill is being promoted to include the shingles vaccine, which is classified as a premium vaccine, in the National Immunization Program,(NIP). On the 19th, Yoo Sang-beom, a member of the United Future Party announced that it had proposed a bill with the same content. He explained that the onset of shingles markedly lowers the quality
- Policy
- Global companies expand business in expensive orphan drugs
- by Lee, Tak-Sun Aug 20, 2020 06:24am
- As global pharmaceutical companies are on to expanding businesses in drugs for rare diseases, the companies are now winning item approvals in South Korean markets. Rare diseases have limited patient size and insufficient treatment options, but the drugs are expensive enough for the companies to seek for profit. On Aug. 19, Ministry of Fo
- Policy
- Drug Approval system under direct control of the MFDS
- by Lee, Tak-Sun Aug 20, 2020 06:23am
- Drug Approval System, which was in charge of the National Institute of Food and Drug Safety Evaluation, will be carried out at the headquarters of the MFDS. The 'Convergence Innovation Product Support Group', a temporary organization that has been in charge of licensing affairs since last year, is formally incorporated into a department under t
- Policy
- Kwang Dong is continuing the business of Pomalyst
- by Lee, Tak-Sun Aug 20, 2020 06:23am
- Kwang Dong is continuing the business of specializing anticancer drug first generics by challenging the patent for Celgene's multiple myeloma treatment 'Pomalyst' (Pomalidomide). Recently, Kwang Dong is showing a prominence in the anticancer drug business by introducing the first generic drug for multiple myeloma treatment, Revlimid and b
- Policy
- Chong Kun Dang recruits consignment companies for Atozet
- by Lee, Tak-Sun Aug 19, 2020 06:28am
- Chong Kun Dang submitted an application for approval in April for Atorvastatin-Ezetimibe, generic for Atozet and recruiting consignment companies is also gaining popularity. Chong Kun Dang applied for item approval of Atorvastatin-Ezetimibe through its own clinical trial. Considering the maximum period of 6 months for the approval review p
- Policy
- No more approval on all appetite suppressants
- by Lee, Tak-Sun Aug 19, 2020 06:28am
- New approval on appetite suppressant amfepramone, also known as diethylpropion hydrochloride, and mazindol drugs would be restricted. These substances were added to the list of restricted approval substance due to the risk of abusing narcotics for medical purposes. Now, the list of restricted narcotic drugs includes amfepramone, mazindol
- Policy
- Vaccine by Novavax, produced by SK Bioscience
- by Kim, Jung-Ju Aug 19, 2020 06:27am
- The government has signed a letter of intent (LOI) for cooperation in domestic production and supply in order to smoothly supply the vaccine developed overseas for COVID-19. The domestic supply chain is SK Bioscience, which has joined the production of AstraZeneca products. The MOHW (Minister Park Neung Hoo) at SK Bioscience Research Insti
- Policy
- Development of generic for Pelubi is active
- by Lee, Tak-Sun Aug 18, 2020 06:03am
- Daewon Pharm’s anti-inflammatory generics for Pelubi, which recorded an outpatient prescription of &8361;28.9 billion last year, is actively developing. In July, the first application for permission of generic for Pelubi was received, and nine bioequivalence test plans were approved this year. Generic companies are now developing not onl
- Policy
- Zolgensma was added to target diseases
- by Lee, Tak-Sun Aug 18, 2020 06:02am
- The minutes of the Central Pharmaceutical Affairs Review Committee were released in connection with the expansion of the target age of the expensive drug 'Zolgensma' of &8361;2.5 billion, and it was revealed that the target disease was added on the 3rd. The committee presented a negative opinion on the expansion of the age group, but Orph
- Policy
- MFDS imposes fine on imported Nesina Met and Xeomin
- by Lee, Tak-Sun Aug 14, 2020 06:22am
- Takeda Pharmaceuticals Korea’s antidiabetic drug Nesina Met and other imported drugs have received administrative measure from Korea’s Ministry of Food and Drug Safety (MFDS). Specifically for Nesina Met, the importer would be responsible for the health authority’s 30.15 million won fine that substituted a three-month sales ban.
