- Policy
- The National Assembly is trying to enact GMP legislation
- by Lee, Jeong-Hwan May 6, 2021 06:07am
- As domestic pharmaceutical manufacturers' GMP (Good Manufacturing Practice) violations occur one after another, the National Assembly and the MFDS are struggling to prevent recurrence by strengthening regulations. The National Assembly is considering reinforcing the administrative disposition of pharmaceutical companies violating GMP thr
- Policy
- We must do our best to develop domestic vaccines
- by Lee, Jeong-Hwan May 6, 2021 06:07am
- President Moon Jae-in received a report on the 3rd that "The introduction and vaccination of COVID-19 vaccine is faster than originally planned, and if the amount of introduction by time is as efficiently as possible, the vaccination target for the first half could be raised from 12 million to 13 million. " President Moon presented an opinio
- Policy
- The Vice Minister of Health and Welfare received AZ vaccine
- by Kim, Jung-Ju May 6, 2021 06:06am
- The health and quarantine authorities and the head of the KMA met together to get the AstraZeneca (AZ) COVID-19 vaccine and agreed to overcome COVID-19. Kang Do-tae, the second vice minister of the MOHW, visited COVID-19 Vaccination Center in Yongsan-gu, Seoul on the 3rd to check the vaccination progress and encouraged the officials. Vice
- Policy
- Samyang Holdings is expanding generics for anticancer drug
- by Lee, Tak-Sun May 4, 2021 05:55am
- Last month, Samyang Holdings, which merged with Samyang Biopharm, a subsidiary specializing in pharmaceutical bio, is expanding generics for anticancer drug business. In January, following generic for Votrient (Pazopanib HCl), a kidney cancer treatment, it is also developing generic for Sutene (Sunitinib Malate). Votrient and Sutene curren
- Policy
- MFDS designates 3 new orphan drugs including asciminib
- by Lee, Tak-Sun May 4, 2021 05:55am
- On May 3rd, the Ministry of Food and Drug Safety (MFDS) newly designated 3 drugs including ‘asciminib,' which is used for the treatment of rare leukemia and breast cancer, as orphan drugs. Also, MFDS announced that it will extend the indication for ‘ibrutinib,’ and designate drugs used for neonatal hypoxic-ischemic encephalopathy as developme
- Policy
- Combination of Forxiga + Januvia was applied for permission
- by Lee, Tak-Sun May 4, 2021 05:55am
- It was found that two companies applied for a combination drug license that combines Forxiga (Dapagliflozin Propanediol Hydrate, AZ), a SGLT-2 inhibitory family, leading the diabetes treatment market, and Januvia (Sitagliptin Phosphate Hydrate, MSD), a DPP-4 inhibitory class. Combination of Forxiga+Januvia has not yet been approved in Ko
- Policy
- Afstyla will be reimbursed from June
- by Kim, Jung-Ju May 4, 2021 05:55am
- SK Chemicals' self-developed hemophilia treatment Afstyla (Lonoctocog Alfa (blood coagulation factor VIII, genetic recombination) ) finally passed the Health Insurance Policy Committee. It took 15 months after obtaining a domestic permit and one year after applying for insurance registration. The start of benefits was set on June 1, when supp
- Policy
- MFDS, "will make all efforts to pass and land the 1+3 bill"
- by Lee, Jeong-Hwan May 3, 2021 05:54am
- The Ministry of Food and Drug Safety announced its plan to pass the revised Pharmaceutical Affairs Act at the National Assembly's plenary session and soft-land the system afterward. The revised Act contains a clause that limits the number of consignees to three for each company that conducts the bioequivalence test for generics and drugs
- Policy
- The number of COVID-19 vaccinations exceeded 3 million
- by Kim, Jung-Ju May 3, 2021 05:53am
- The cumulative value of the first vaccination patients who received COVID-19 vaccine exceeded 3 million. The quarantine authorities achieved the cumulative amount of vaccinations one day earlier than the initial target set by the quarantine authorities, and the authorities predict that 12 million vaccinations in the first half can be carri
- Policy
- There is no problem with AZ vaccine safety
- by Kim, Jung-Ju Apr 30, 2021 06:09am
- The government announced that it is concerned about the avoidance of the AstraZenega (AZ) COVID-19 vaccine due to the thrombosis side effect issue. It is said that there are no safety issues with side effects and solutions that appear around the world. Son Young-rae, Team Leader of Countermeasure Headquarters COVID-19 Social Strategy, ans
