News About: Goverment
Rapid approval of generic drugs eyed
The Korea Food and Drug Administration announced on April 5 it has revised the rule concerning the screening of safety and efficacy of drugs, etc. as part of its effort to provide better support for the domestic drug ...
Disclosure of substandard drugs to be compulsory
A drug maker, importer or distributor will be required to immediately withdraw or undertake an appropriate withdrawal program against substandard drugs whenever they are found to be harmful.
The term substandard is...
Submission of bioequivalence test reports to be extended
The deadline for the bioequivalence test reports of about 250 drugs may be extended, as a number of pharmaceutical firms have failed to submit their test protocols because of a higher cost and tighter schedule, accord...
FTA will encourage more competitiveness of Korean drug makers, health ministry saysThe Ministry of Health and Welfare said on April 2 that the free trade agreement (FTA) reached between Korea and the U.S. will help enhancing the competitive power of local drug...
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Concerns growing over public health
The end of the free trade agreement (FTA) will be a big blow to Korean pharmaceutical firms that rely much of the revenue on the sales of generic drugs, and also threaten the government's ability to control the prices...
FTA to batter generic drug business and raise patent disputes.
It is expected that the KORUS FTA settlement may raise a lot of patent disputes between the original drug companies and generic drug manufacturers, and if any patent lawsuit be raised, its copy drug registration may b...
FTA negotiation battles on pharmaceutical issues ended in defeat.
9 round talks on the KORUS FTA negotiations since June last year were finally settled down.
The pharmaceutical issues were one of the hottest subjects to an extent that during the 2nd talks in Seoul, the U. S. nego...
Korea to cover cost-effective medicines
The government plans to permit the national health insurance to cover only cost-effective drugs to reduce snowballing medication costs as an increasing number of patients are taking more expensive and diverse dr...
Novartis Korea, KFDA mulls voluntary withdrawal of Zelmac
Novartis Korea said on April 2 it discussed with the Korea Food and Drug Administration on the possibility of Zelmac (tegaserod) withdrawal from the market.
The U.S. Food and Drug Administration said on March 30 th...
Labeling changes for 39 drugs
The Korea Food and Drug Administration said it has approved labeling changes for 39 items from 26 pharmaceutical firms based on the evaluation of its safety information.
An observation reported in the labeling is t...
