- Policy
- Billing for α-GPC is managed
- by Lee, Jeong-Hwan Jun 28, 2021 05:50am
- The HIRA plans to consider the need to manage claims by selecting Choline alfoscerate, which is under controversy over reducing adaptation certificates, as the "selection focused item." The MFDS plans to periodically monitor pharmaceutical companies that have been clinically reassessed, block unnecessary clinical extensions, and take ad
- Policy
- The number of items has plummeted due to regulatory impact
- by Lee, Tak-Sun Jun 28, 2021 05:49am
- Recently, More and more items are being removed due to the expiration date. Pharmaceutical companies have sorted out the items due to strong regulations on impurities and penalties for drug prices of consignment items. According to the MFDS on the 23rd, a total of 63 new drugs have been approved this month. On the contrary, there are 226 item
- Policy
- NA LJC to review ‘1+3 bill for generics’ tomorrow
- by Lee, Jeong-Hwan Jun 25, 2021 05:51am
- The National Assembly's Legislation and Judiciary Committee will review the revision of the Pharmaceutical Affairs Act that contains the bill for the ‘1+3 restriction for bioequivalence and clinical test’ of generics and drugs requiring data submission an agenda for review at the NA Legislation and Judiciary Committee’s general meeting th
- Policy
- MFDS investigates impurities of Sartan and Varenicline
- by Lee, Tak-Sun Jun 25, 2021 05:50am
- The MFDS has launched a full investigation as the risk of impurities in Sartan and Varenicline, a non-smoking treatment supplement, has been raised among hypertension drugs. Recently, some products have been recalled due to the detection of impurities such as carcinogens in Canada and other countries. However, in the case of Sartan, both r
- Policy
- Zopista's price cut by 23%, Gefitinib by 22%
- by Kim, Jung-Ju Jun 24, 2021 05:54am
- The premium pricing period for Huons' Zopista has ended., and the price will fall by 23.9% at most for its strengths. Also, Hanmi Pharmaceutical applied for a voluntary price cut of its ‘Gefitinib Tab,’ and its price will fall by 22.1%. The premium pricing term for five zoledronic acid monohydrate products including Boryung Pharmaceuticals’
- Policy
- Leclaza will be reimbursed for non-small cell lung cancer
- by Lee, Hye-Kyung Jun 24, 2021 05:54am
- From July 1, Yuhan Corporation's "Leclaza (Lazertinib)" will be reimbursed at the stage of secondary administration of non-small cell lung cancer. The HIRA announced that it will conduct an opinion inquiry until the 25th on the revised announcement (proposal) based on drugs prescribed and administered to cancer patients. If there is no dis
- Policy
- Standards for Trelegy Ellipta will be established
- by Kim, Jung-Ju Jun 24, 2021 05:54am
- Five drugs, including Trelegy Ellipta, a treatment for COPD are scheduled to be registered for insurance in accordance with next month's schedule, and salary standards will be established and changed accordingly. The MOHW has partially amended its notice of 'details on the criteria and methods of applying care benefits' to ensure proper i
- Policy
- Janssen's Sporanox is also expected to convert to imports
- by Lee, Tak-Sun Jun 22, 2021 05:50am
- Janssen Korea, which has decided to operate its Hyangnam plant by this year, will also import the antifungal drug "Sporanox (Itraconazole)." As a result, co-marketing with Yuhan is expected to end. According to industries on the 21st, Janssen's Sporanox Cap is going to convert its imports by changing its license at the end of June. Sporanox
- Policy
- Quality issues alarmed the pharmaceutical industry
- by Jun 22, 2021 05:50am
- Recent cases of GMP violations by Korean pharmaceutical companies have served as an opportunity to guard against risks throughout the industry. In addition, there are opinions that it should be improved in the wake of this incident. Until now, actual changes in standards for GMP have been sluggish according to global level. Only a few compani
- Policy
- Closing the opinion gap important for the generic '1+3 bill'
- by Lee, Jeong-Hwan Jun 21, 2021 05:51am
- With the bill limiting the participating generic makers to three consignees per consignor when conducting joint biological equivalence tests or clinical tests awaiting review by the National Assembly’s Legislation and Judiciary Committee., whether the opinion gap between the large pharmaceutical companies and small- and medium-sized pharm
