- Policy
- Innovative pharmaceutical companies' new drug tx
- by Lee, Jeong-Hwan Oct 7, 2022 06:03am
- It was also pointed out that the government is delaying the preparation of a sub-law of a clause that favors the price of new drugs developed by innovative pharmaceutical companies in the Special Act on the Promotion of the Pharmaceutical Industry. Critics say that it has not been active in subsequent legislation such as enforcement ordinance
- Policy
- The incidence of adverse effects in Alecensa is 80%
- by Lee, Hye-Kyung Oct 6, 2022 06:05am
- A five-year post-marketing survey (PMS) of the Anaplastic Lymphoma Kinase (ALK) mutant non-small cell lung cancer treatment Alecensa 150mg showed 1012 significant drug abnormalities that could not rule out causality. The permit will be changed with 20 and 122 cases of serious drug adverse reactions and unexpected drug adverse reactions that c
- Policy
- MFDS prepares clinical trial guidelines for COVID-19 drugs
- by Lee, Hye-Kyung Oct 6, 2022 06:05am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) published and distributed the ‘Clinical trial guideline on antiviral treatments for mild-to-moderate COVID-19 infections’ to support the rapid development of COVID-19 antivirals by guiding companies on the new clinical outcome parameters and methods for designing flexible clinica
- Policy
- Data for reevaluation to be submitted from the 24th
- by Lee, Tak-Sun Oct 5, 2022 06:11am
- The data submission system for reevaluation of listed drugs that was set to be operated as of the 1st of this month will be operated from the 24th. The authorities plan to receive data submitted before then through the Health Insurance Review and Assessment Service’s e-mail. With the data submission system not being initiated in time, t
- Policy
- Pfizer Corona vaccine passed a verification advisory group
- by Lee, Hye-Kyung Oct 5, 2022 06:10am
- The Ministry of Food and Drug Safety (Director Oh Yoo-Kyung) announced on the 30th that Pfizer Pharmaceutical's COVID-19 vaccine "Comirnaty 2 0.1mg/mLP (Initial Virus of COVID-19, Omicron (BA.1)") passed the COVID-19 vaccine safety and effectiveness verification advisory group. The advisory group held a meeting on the 29th and proved its
- Policy
- Post-marketing surveillance of breast cancer drug Kadcyla
- by Lee, Hye-Kyung Oct 4, 2022 06:07am
- A total of 31 serious adverse reactions (ADRs) whose causal relationship cannot be ruled out had been reported as results of the 8-year post-marketing surveillance (PMS) on Roche Korea’s second-line breast cancer treatment ‘Kadcyla (trastuzumab emtansine).’ With 163 additional cases of unexpected ADRs whose causal relationship cannot b
- Policy
- The price of Zerbaxa is listed at 60,098 won
- by Kim, Jung-Ju Oct 4, 2022 06:07am
- Zerbaxa, called the next-generation antibiotic for MSD Korea, will be listed at 60,098 won per vial as of the 1st of next month. Yuhan Corporation's allergic rhinitis treatment Ryaltris nasal spray 18ml is listed at 6,197 won and Ryaltris nasal spray 31ml is listed at12,396 won, respectively. The Ministry of Health and Welfare held a healt
- Policy
- Strengthen the guarantee of 21 new drug by the third quarter
- by Kim, Jung-Ju Sep 30, 2022 05:53am
- From January to the third quarter of this year, a total of 21 new drugs were newly listed on the drug benefit list or improved access to use due to expanded insurance benefit standards. Among them, two new drugs were newly listed on the drug benefit list this month. The number of domestic patients estimated to benefit or suffer from the gover
- Policy
- Reevaluation deadline for listed drugs extended 5 months...
- by Kim, Jung-Ju Sep 30, 2022 05:53am
- The government finalized its plan to extend the deadline for reimbursed price reevaluations of listed drugs that are subject to conduct bioequivalence tests and made a final report to the top legislative organization for the national health insurance. The finalized plan will extend the data submission period of listed drugs that are subject
- Policy
- Research service for re-evaluation of listed drug benefits
- by Lee, Tak-Sun Sep 30, 2022 05:53am
- The HIRA will conduct a study on the re-evaluation of drug benefit adequacy with the aim of ending in February next year. Through this, it will be used as a policy to promote re-evaluation projects. The HIRA announced on the 27th that it would bid for a research service to rationalize the evaluation of drug benefit adequacy. Ticketing is sche
