- Policy
- Cases of Vivozon & Binex need ‘1+3 Regulation Act’
- by Lee, Jeong-Hwan Mar 15, 2021 06:29am
- Following Binex, Vivozon illegally manufactured medicines in violation of the Pharmaceutical Affairs Act. As a result, the '1+3 Regulation Act' legislation that directly limits the number of drug became valid. The reason was the domestic licensing system and regulatory environment in which too many generics could obtain marketing licenses.
- Policy
- AZ vaccination recommended for age 65 or older
- by Kim, Jung-Ju Mar 15, 2021 06:28am
- The Vaccination Specialist Committee recommended AstraZeneca COVID-19 vaccination for people 65 years of age or older. Accordingly, the quarantine authorities decided not only to immunize them, but also to immunize patients and workers in nursing hospitals and facilities during this month. The COVID-19 Vaccination Promotion Team (Dire
- Policy
- MFDS drug review result to be disclosed within 2 months
- by Lee, Tak-Sun Mar 12, 2021 06:23am
- The pharmaceutical review result for new drug would be disclosed within two months from the completed date. Compared to four months taken at the moment, the information disclosure deadline would be cut by two months. Regardless of the affected company’s request for non-disclosure, the summarized information would be publicly opened to impro
- Policy
- 3 drugs including Baricitinib are covered for COVID-19 tx
- by Kim, Jung-Ju Mar 12, 2021 06:22am
- Baricitinib, Corticosteroids, low-molecular weight heparin, and anticoagulants are covered to be used to COVID-19 confirmed patients. Kaletra (Lopinavir + ritonavir), Hydroxychloroquine, and Ribavirin were decided to be removed from the benefit. The MOHW decided to partially revise the notification of details on the application standar
- Policy
- SK-manufactured AZ vaccines for export exceeds domestic use
- by Lee, Tak-Sun Mar 12, 2021 06:22am
- The volume of AstraZeneca COVID-19 vaccine manufactured at SK Bioscience Andong plant for export cleared for lot release has exceeded the volume for domestic supply. The AstraZeneca Korea COVID-19 Vaccine manufactured by SK Bioscience was authorized on Feb. 10, which the National Lot Release cleared 1.57 million doses of it on Feb. 17. S
- Policy
- Italy restricts export of AZ vaccine, including Korea
- by Lee, Tak-Sun Mar 11, 2021 06:07am
- It is an analysis that the EU's policy to restrict the export of the COVID-19 vaccine produced in Korea is highly likely to affect Korea. In particular, it is expected that the recent restriction on the export of AstraZeneca vaccine produced in Italy to Australia could directly affect the supply and demand of vaccines in Korea. This is be
- Policy
- MFDS reviews sales ban on Binex-manufactured generics
- by Lee, Jeong-Hwan Mar 10, 2021 06:27am
- The impact of the allegation on Binex manipulating the manufacturing method and active ingredient dosage in six drugs including antidiabetics and antidepressants is snowballing within the pharmaceutical industry. Source confirmed South Korea’s Ministry of Food and Drug Safety (MFDS) has started reviewing administrative measure to be o
- Policy
- Sales of 6 BINEX items have been temporarily suspended
- by Lee, Jeong-Hwan Mar 10, 2021 06:27am
- he MFDS decided on the 8th to temporarily suspend the manufacture and sale of six medicines manufactured by BINEX and to collect them. The MFDS is also launching an investigation into a factory located in Busan. Drugs subject to disposal are Amorin (Glimepiride), Xelectin (Fluoxetine), Daxfen (Dexibuprofen), Rofsin 250 mg (Ciprofloxacin)
- Policy
- Promote disclosure of anticancer drug Expedite Review result
- by Kim, Jung-Ju Mar 9, 2021 06:24am
- A revision of the law is being promoted to revise up the relevant laws and regulations, so-called Fast Track (Expedite Review) for drugs that treat serious diseases, such as anticancer drugs and AIDS drugs, and make the review process transparently disclosed. On the 5th, Rep. Nam In-soon of the Democratic Party of Korea, a member of the Na
- Policy
- Soliris follow-on Ultomiris conditionally listed
- by Lee, Hye-Kyung Mar 9, 2021 06:24am
- Handok’s paroxymal nocturnal hemoglobinuria (PNH) treatment Ultomiris (ravulizumab) is getting closer to the National Health Insurance (NHI) reimbursement. On Mar. 4, the Health Insurance Review and Assessment Service (HIRA) convened a second meeting of the year for the Drug Reimbursement Evaluation Committee (DREC) and deliberated list
