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2025-09-09 23:06
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Policy
MFDS's bill on stable supply of essential drugs in review
by
Lee, Jeong-Hwan
Aug 20, 2025 06:22am
A bill to add ¡°medicines that are essential for healthcare and require stable supply¡± and ¡°medicines with similar therapeutic effects with no alternative treatments¡± to the list of national essential medicines, thereby resolving the issue of unstable supply of medicines, is likely to pass the Health and Welfare Committee's legislative su
Policy
MOHW proposes an alternative to law on generic substitution
by
Lee, Jeong-Hwan
Aug 19, 2025 06:11am
A revision to the Pharmaceutical Affairs Act that would allow pharmacies to report generic substitution to the Health Insurance Review and Assessment Service (HIRA) through its work portal is likely to pass the National Assembly. The background to the sudden increase in the likelihood of legislation is that the Ministry of Health and Welf
Policy
Periodic drug price system reform included as national task
by
Lee, Jeong-Hwan
Aug 18, 2025 06:02am
The government has selected a policy to improve the drug price calculation system and establish a periodic drug price adjustment mechanism as part of its national policy task, with the goal of ensuring the sustainability of health insurance, and is pushing ahead with its implementation. Depending on the specific details of the national po
Policy
Gilead¡¯s Yescarta approved in KOR...3rd CAR-T therapy
by
Lee, Hye-Kyung
Aug 14, 2025 06:13am
The third CAR-T therapy has been approved in Korea. The Ministry of Food and Drug Safety approved Gilead Sciences Korea's Yescarta (axicabtagene ciloleucel) today (13th). Yescarta is a CAR-T therapy that received approval from the U.S. FDA in 2017 and the European EMA in 2018. Last year, the EMA approved it as a second-line treatment f
Policy
New drug approval fees ₩410mil in KOR
by
Lee, Hye-Kyung
Aug 13, 2025 06:07am
Since the new drug approval fee was significantly increased to KRW 410 million starting this year, a total of 14 new products containing 10 ingredients have been submitted for approval. Although the specific product names cannot be disclosed, dedicated teams have been formed for 6 chemical drug substances and four biopharmaceutical substances, a
Policy
Smokers at 54.5 times higher risk of SCLC than non-smokers
by
Lee, Tak-Sun
Aug 12, 2025 06:13am
A study has found that 30-year smokers have a 54.5 times higher risk of developing small cell lung cancer than non-smokers. The National Health Insurance Service (NHIS) Health Insurance Policy Research Institute announced on the 11th the results of a comparative analysis of cancer incidence risk and attributable risk by cancer type among indi
Policy
Will RSV vaccines be included in the NIP?
by
Whang, byung-woo
Aug 8, 2025 06:03am
With the RSV (respiratory syncytial virus) vaccine being released in Korea this year, interest in its inclusion in the National Immunization Program (NIP) has been gaining attention. According to the National Assembly's legislative information system, on the 6th, Rep. Yong-ki Jeon of the Democratic Party of Korea introduced a bill titled ¡°Pa
Policy
Gov¡¯t sets criteria for drug shortage prevention
by
Lee, Hye-Kyung
Aug 7, 2025 06:06am
The government will improve the criteria to raise the prices of drugs essential for patient treatment. Specifically, it will establish detailed evaluation criteria for price adjustment requests submitted by pharmaceutical companies that deem the current insurance price ceiling unreasonable. Prime Minister Min-seok Kim chaired the 7th Bioh
Policy
H1 Pharma exports amounted to $5.38B
by
Lee, Hye-Kyung
Aug 7, 2025 06:05am
In the first half of this year, healthcare industry exports increased by 13.2% compared to the same period last year, reaching $13.79 billion, an all-time high for a half-year period. By sector, exports were led by cosmetics at $5.51 billion (+14.9%), pharmaceuticals at $5.38 billion (+20.5%), and medical devices at $2.91 billion (¡â0.6%).
Policy
Faslodex¡¯s price stays as is¡¦supply instability concerns
by
Lee, Tak-Sun
Aug 5, 2025 06:08am
The breast cancer drug Faslodex (fulvestrant, AZ Korea), was facing a price cut due to the expiry of its premium pricing period, but this was prevented by the pharmaceutical company's request for a stay of execution. On the 31st of last month, the MOHW announced that the court had temporarily suspended the execution of the disposition to
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