- Policy
- Anticipated shortage of Merck’s fertility drug ‘Gonal-F’
- by Lee, Hye-Kyung Mar 15, 2024 05:49am
- The shortage of Merck’s 'Gonal-F Pen,' which is the world’s first recombinant follicle stimulating hormone (r-FSH), is expected. Merck has announced that three, 300/450/900IU, of the four volumes of Gonal-F Pen approved by the Ministry of Food and Drug Safety (MFDS) are expected to be short in supply. Currently, the 150IU volume is in
- Policy
- Gov't will specify scope of expense report details disclosed
- by Lee, Jeong-Hwan Mar 15, 2024 05:49am
- The Ministry of Health and Welfare recently met with physician and pharmacist organizations and the pharmaceutical, biotech, and medical device industries to collect opinions on setting the ‘scope of disclosure of expense reports’ that are prepared to report the expenses legally paid by pharmaceutical and biotech companies and medical de
- Policy
- HIRA’s CDDC seeks to revise current regulations
- by Lee, Tak-Sun Mar 15, 2024 05:48am
- The current regulation that randomly selects members for each Cancer Disease Deliberation Meeting will be deleted. The measure was prepared to maintain consistency in the committee’s deliberations. In addition, the Korean Association for Lung Cancer will be added as a recommended organization given that lung cancer drugs are often on th
- Policy
- MFDS starts regulatory innovation program for Big Techs
- by Lee, Hye-Kyung Mar 14, 2024 05:42am
- The Ministry of Food and Drug Safety (MFDS) announced that will be operating a ' 2024 Big Tech Company Regulatory Innovation Program’ again this year to provide continuous regulatory support to domestic digital medical device companies. Last year, the MFDS identified the exact needs of the industry through the Big Tech Company Regulatory
- Policy
- Chong Kun Dang also enters low-intensity atorvastatin mkt
- by Lee, Hye-Kyung Mar 14, 2024 05:42am
- Amid fierce competition in the hyperlipidemia drug market to develop 2nd generation ‘statin + ezetimibe’ combination drugs using low-strength statins, some low-dose atorvastatin products are also soon to enter the market. On the 12th, the MFDS approved Chong Kun Dang's ‘Lipilou Tab 5mg.’ It is a 5 mg low-strength single tablet that co
- Policy
- Poteligeo and Livtencity may likely be reimbursed in April
- by Lee, Tak-Sun Mar 14, 2024 05:42am
- Two rare disease drugs, Poteligeo (mogamulizumab, Kyowa Kirin Korea) and Livtencity (maribavir, Takeda Pharmaceuticals Korea), are likely to be added to the reimbursement list next month after completing pricing negotiations with the National Health Insurance Service. According to industry sources on the 13th, the companies have complet
- Policy
- “Calling for promotion of substitute drug dispensation“
- by Lee, Jeong-Hwan Mar 13, 2024 05:32am
- The Ministry of Health and Welfare (MOHW) announced that they are not officially reviewing specifics of a potential policy to promote the dispensing of substitute drugs. Yet, the MOHW agreed on the need to promote the dispensing of a substitute drug for the drug prescribed in a prescription. Promoting the dispensation of substitute drug
- Policy
- Companies with superior CP ratings get reduced fines
- by Lee, Jeong-Hwan Mar 13, 2024 05:32am
- The Korea Fair Trade Commission announced the enforcement of the amendment to the Enforcement Decree of the Fair Trade Act, which grants up to a 20% penalty reduction to companies that receive superior ratings through the operation of a Compliance Program (CP), drawing industry-wide attention. Companies that have been operating for more t
- Policy
- ‘A multifaceted approach to reimburse high-priced drugs'
- by Lee, Jeong-Hwan Mar 13, 2024 05:32am
- It has been pointed out that a financial management plan needs to be established for high-priced drugs listed through the general system, as well as a system to evaluate and manage the performance of high-priced drugs that were granted reimbursement through the risk-sharing agreement (RSA) scheme in order to manage the soundness of the Natio
- Policy
- 1st KOR trial of 'STX-721' to treat EGFR mutant NSCLC begins
- by Lee, Hye-Kyung Mar 11, 2024 05:55am
- The US pharmaceutical company Scorpion Therapeutics has started conducting the first clinical trial of its new EGFR-targeted therapy, 'STX-721,' on patients in South Korea. The Ministry of Food and Drug Safety (MFDS) has approved ‘The first human clinical trial of STX-721 enrolling patients with locally advanced or metastatic non-small cell
