- 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
- Policy
- Gov will proactively improve system for severe psoriasis
- by Kim, Jung-Ju Jun 21, 2021 05:50am
- With a year left before the re-registration of special exemption of insurance calculation for severe psoriasis, the government, payer, and patient group gathered to discuss improvement. The issue discussed was that despite reimbursement approved for severe psoriasis drugs, patients are not being properly covered as the eligibility standards for
- Policy
- Yuhan's Raboni-D has been licensed
- by Lee, Tak-Sun Jun 21, 2021 05:50am
- Yuhan, which had a high dependence on sales for imported drugs, has recently been speeding up with the commercialization of new drugs such as Lazertinib and IMD. In particular, Yuhan refrains from entrusting or entrusting developing products and is building market competitiveness with its own products. The MFDS approved "Raboni-D," Yuhan's
- Policy
- An exception to the 1+3 Bill for IMD
- by Lee, Jeong-Hwan Jun 18, 2021 05:54am
- A letter from a pharmaceutical representative to the National Assembly affected the process of the National Assembly's Health and Welfare Committee's handling of generics, drug for data-based re-evaluation "1+3 bill." It was reflected in the revised schedule when a representative of company A sent a petition to 24 members of the National A
- Policy
- 559 doctors warned for wrongful prescription of Zolpidem
- by Lee, Tak-Sun Jun 18, 2021 05:53am
- After analyzing the prescription information on the Narcotics Information Management System (NIMS), the Ministry of Food and Drug Safety announced its decision to issue written ‘warnings’ to 559 doctors that have continuously prescribed or used Zolpidem beyond the safe use standards to prevent abuse and promote proper use of the medical narcot
- Policy
- “The 1+3 bill” was passed by the Welfare Committee
- by Lee, Jeong-Hwan Jun 18, 2021 05:53am
- The 1+3 bill passed a plenary session of the National Assembly's Health and Welfare Committee on the morning of the 16th and will be reviewed by the legislation and judiciary committee. The resolution reflected the revision of the supplementary provision, which excludes the report from the MFDS within a month from the enforcement date of t
- Policy
- Moderna vaccine has been approved for lot release
- by Lee, Tak-Sun Jun 18, 2021 05:53am
- The MFDS said it approved lot release of 55,000 doses of Moderna COVID-19 vaccine on the 15th. The national lot release is a system in which country evaluates the results of the verification test and the review of the manufacturer's data before the vaccine is distributed on the market and checks the quality once more. The MFDS measured
- Policy
- AZ vaccine's side effects are reviewed
- by Lee, Tak-Sun Jun 17, 2021 08:02pm
- The MFDS has begun a review on the addition of side effects of capillary leakage syndrome of AstraZeneca's COVID-19 vaccine recommended by the European Medicines Agency (EMA). The MFDS announced on the 14th that it will take necessary measures such as distributing Dear Healthcare Professional Letter, sharing information recommended by EMA,
