News About: Goverment


Government, “No damage on medical field from Moon Jae-In Care”

The Ministry of Health and Welfare(MOHW) stressed health care service providers, such as pharmacies, dentists and Korean medicine doctors, would not take any tangible damage from the Moon Jae-In Care at this year’s he...

MFDS establishes Korean version of Orange Book, ‘Generic Drug Approval and Evaluation Information Platform’

The Korean version of Orange Book called ‘Generic Drug Approval and Evaluation Information Platform’ will be created. The Ministry of Food and Drug Safety presented key business directions and system improvements for...

Companies will be obligated to make drug exporting reports from next year

Starting next year, companies which sell drugs will be obligated to make reports about their exporting performance, and they will be imposed a fine for violating this obligation. The Ministry of Food and Drug Safety(...

MOHW, MSIP and MOTIE carry out ‘National New Drug Development Support Project’

The 3 government bodies, Ministry of Health and Welfare(MOHW), Minister of Science, ICT and Future Planning(MSIP) and Ministry of Trade, Industry and Energy(MOTIE), will study proprietary of the ‘National New Drug Dev...

‘Bio-Health Big Data’ to be established of 50 million people from 39 hospitals for personalized new drugs

Medical data of 50 million people from 39 hospitals will be established as virtual big data by 2020, which will empower tailored new drugs, developed of medical devices and personalized healthcare services. The Minis...

Average settlement rate for drug price negotiations for 12 years is 91%

The average settlement rate of all the drug price negotiations after the drug price negotiation system is 91.2%, but for the past 2 years were 98.8% in 2016 and 98.6% in 2017, showing a higher rate. The total 455 new...

Pharmas are able to manufacture only 1% for small-packaged medicines with low demands

The government will revise regulations which allow pharmaceutical companies to manufacture only 1% if having low demands for small packaging. The Ministry of Food and Drug Safety recently held the small packaging com...

Erbitux renews RSA for the first time

Erbitux, a metastatic rectal and colon cancer therapy, successfully renewed the RSA agreement. This is the first case which renewed the agreement through a renegotiation. According to the National Health Insurance Se...

Nutritious injections to be excluded from active pharmaceutical ingredient registration

Nutritious injections will be excluded from the list of active pharmaceutical ingredient registrations. In order to keep drug safety and quality control. The Ministry of Food and Drug Safety(MFDS) pre-announced the ...

Government will disclose ‘selective registration of drugs’ such as anticancer drugs at Health Insurance Policy Deliberation Committee this May

Mentioned at the Moon Jae-In Care(National Health Insurance Coverage Extension Plan), articles about selective health insurance benefits for 48 types of medicines, such as anticancer drugs, are expected to be proposed...

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