- Policy
- Janssen’s Spravato required to submit domestic trial data
- by Lee, Hye-Kyung Feb 13, 2024 05:51am
- With Janssen’s novel drug for treatment-resistant depression (TRD), ‘Spravato Nasal Spray (esketamine hydrochloride)’ failed to demonstrate efficacy in Japanese and Chinese patients, the Korean authorities also held discussions on whether to maintain its marketing authorization status in Korea as well. The drug was approved in June 2020.
- Policy
- Good pharma companies will receive better drug price
- by Lee, Jeong-Hwan Feb 8, 2024 05:49am
- The government decided to further enhance the preferential drug pricing benefits for pharmaceutical companies that have contributed to public health and economic development in Korea, such as by increasing R&D investment in new and incrementally modified drugs, creating many jobs, and supplying essential medicines. The government will p
- Policy
- Korean gov. to introduce preferential drug pricing criteria
- by Lee, Jeong-Hwan Feb 8, 2024 05:49am
- By the first half of this year, the government plans to establish a detailed criteria for ‘National Economic Growth,’ including the research and development (R&D) of new drugs and incrementally modified drugs, essential drugs supply, and new job creations, which will be the basis for preferential drug pricing intended for pharmaceutical
- Policy
- Production and supply of Cifex Eye Drops is discontinued
- by Lee, Hye-Kyung Feb 8, 2024 05:49am
- Samil Pharm will suspend production and supply of its 2nd generation fluoroquinolone antibiotic eye drop, Cifex Eye Drops (ciprofloxacin hydrochloride hydrate). According to the Ministry of Food and Drug Safety's status report on the discontinued or supply shortage drugs, Samil Pharm had reported the discontinuation of its Cifex Eye Drop
- Policy
- Preferential pricing possible for non-innovative new drugs
- by Lee, Tak-Sun Feb 8, 2024 05:48am
- The government has announced a plan allowing new drugs developed by pharmaceutical companies not designated as Korea’s innovative pharmaceutical companies to be eligible for preferential drug pricing. This has turned attention to whether Jeil Pharmaceutical’s new drugs will benefit from this plan. On the 4th, the Ministry of Health and
- Policy
- HIRA 'Ease entry of new drugs and strengthen post-evals'
- by Lee, Tak-Sun Feb 7, 2024 05:59am
- Jung-Gu Kang, President of the Health Insurance Review and Assessment Service, said that he will lower the barriers to entry for new drugs while strengthening post-listing evaluations. For this, Kang explained that HIRA had established the ‘Pharmaceutical Performance Assessment Department’ to improve the management system of high-pric
- Policy
- Bill for consigned manufacture of advanced biologics
- by Lee, Jeong-Hwan Feb 6, 2024 06:10am
- A bill is being promoted to allow advanced biological products such as cell and gene therapies Kymriah and Zolgensma to be manufactured by government-authorized consignment organizations and facilities. The goal of the bill is to expand the domestic production infrastructure for advanced biological products to reduce the time and cost o
- Policy
- Reimb of Enhertu, Ilaris pass DREC review…deemed adequate
- by Lee, Tak-Sun Feb 5, 2024 05:53am
- High-priced drugs such as Enhertu and Ilaris have passed the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee review. This means that they have crossed the 80% mark to reimbursement, as the drugs can now be covered by health insurance after negotiating drug prices with the National Health Insurance
- Policy
- Price of drugs listed in 2002-2006 may be adjusted next year
- by Lee, Tak-Sun Feb 2, 2024 12:28pm
- The Health Insurance Review and Assessment Service will be selecting drugs subject to reimbursement adequacy reevaluations in 2025. The drugs to be reevaluated next year are expected to be those listed from 2002 to December 2006, before Korea implemented the Positive List System. According to industry sources, the Drug Reimbursement Ev
- Policy
- Referencing lowest A8 price will result in a supply crisis
- by Nho, Byung Chul Jan 29, 2024 06:05am
- Health authorities and the pharma-bio industry are at an impasse over the implementation of 'A8 external reference pricing reassessments.’ Engaged in a tug-of-war, the two parties have difficulty finding common grounds. The Ministry of Health and Welfare, the Health Insurance Review and Assessment Service, the Korea Pharmaceutical and Bi
