- Policy
- When will the CSO reporting system be legislated?
- by Lee, Jeong-Hwan Aug 23, 2022 06:04am
- In consensus, the government and pharmaceutical industry are voicing the need to legislate the pharmaceutical contract sales organization (CSO) reporting system and urging the National Assembly to review the bill. Both the government and pharmaceutical industry share the position that a bill needs to be passed by the National Assembly to
- Policy
- There is no concern about the disposal of COVID-19 PO tx
- by Lee, Jeong-Hwan Aug 23, 2022 06:03am
- Regarding the criticism that many of the COVID-19 PO treatments held by the quarantine authorities are likely to be discarded due to the expiration date early next year, it expressed that there is no problem in proper inventory management. As the use of PO drugs is increasing due to the re-proliferation of COVID-19 and an active prescripti
- Policy
- “Bio-vaccine fund will be created within the year”
- by Lee, Jeong-Hwan Aug 22, 2022 05:53am
- President Yoon Suk-Yeol reconfirmed his new government’s plan to raise and create a K-Bio·Vaccine Fund that focuses investments on Phase III trials within the year. The government will induce investments with pan-ministerial support and also accumulate data on 1 million people to develop next-generation treatments such as advanced bioph
- Policy
- The PVA exception to COVID-19 cold drug is actively applied
- by Lee, Tak-Sun Aug 22, 2022 05:52am
- Pharmaceutical Industry Says "Response After Gathering Internal Opinions" The Ministry of Health and Welfare said it would actively apply the correction method to the pharmaceutical industry's request to exclude cold drugs used in COVID-19 from PVA. Although it is not excluded from the negotiation, the policy is to actively apply exception ru
- Policy
- Manufacturing for development allowed during suspensions
- by Lee, Hye-Kyung Aug 19, 2022 05:53am
- An interpretation that manufacturing activities for the purpose of product development, not for commercial sale, is possible during the manufacturing business suspension disposition period. According to industry sources on the 18th, the Ministry of Food and Safety announced that not-for-sale manufacturing activities, such as those for pr
- Policy
- We need to increase the rate of PO tx for COVID-19 crisis
- by Lee, Jeong-Hwan Aug 19, 2022 05:53am
- In order to respond to the increase in the number of patients with COVID-19, it was pointed out that the prescription rate of treatments such as Paxlovid should be raised more than now, while continuing to maintain an environment where prescriptions are quickly prescribed. It was also suggested that the fast track of the COVID-19 high-risk or
- Policy
- KDCA opposes use of Paxlovid in healthy 50s
- by Lee, Jeong-Hwan Aug 18, 2022 05:48am
- The disease control and prevention authorities have expressed opposition to the plan to lower the prescription age for Pfizer’s oral COVID-19 treatment, Paxlovid, to those in their 50s, on grounds of domestic Emergency Use Authorization standards. The decision was influenced by the fact that eligibility for Paxlovid had already been exte
- Policy
- Why is price different btw patent-expired original/generic
- by Lee, Tak-Sun Aug 18, 2022 05:47am
- The drug price will be lowered to 53.55% of the existing upper limit from the 22nd after losing an administrative lawsuit against the drug price lowered by the anticoagulant Xarelto with the government. As a result, it will be the same as the highest price of generics registered last year. However, the drug price of Xarelto 10mg is expected t
- Policy
- KDCA will announce its plan to inoculate bivalent vaccine
- by Lee, Jeong-Hwan Aug 17, 2022 05:52am
- The domestic quarantine authorities plan to announce vaccination plans at the end of this month, including the subject and use of Moderna's bivalent vaccine for COVID-19 omicron. Moderna bivalent vaccine is still in the pre-application stage, and the intention is to make a plan for use in consideration of the effectiveness and safety of va
- Policy
- Novavax vaccine approved for use for 12+ years in Korea
- by Lee, Hye-Kyung Aug 17, 2022 05:52am
- The age eligibility of Novavax’s COVID-19 vaccine will be extended. The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced that it had approved the Post Approval Change Application for the COVID-19 vaccine ‘Nuvaxovid Prefilled Syringe,’ developed by Novavax and manufactured by SK Bioscience, to change the vaccination ag
