News About: Goverment


Pharmaceutical affairs law to be streamlined

The government plans to streamline the current pharmaceutical affairs law by introducing a renewal system of product license, the Ministry of Health Welfare said on December 13. In the recent scientific congress, S...

Individual small drug package labelling hardly to describe.

The KFDA said that soon or later a provision should be revised for a small drug package including PTP packs to waive its description in viewing that it is practically impossible to indicate such necessary descriptions...

Rules concerning safety and efficacy of drugs, etc. eased

The Korea Food and Drug Administration announced on December 13 that it has revised the rules concerning safety and efficacy of drugs, etc., the salient points of which are as follows: - The conditions of protocol,...

Public hearing on KFDA disorganization issue went abortive.

The public hearing plan on Dec. 12 for the issue of revised government organization act covering a new establishment of the Food Safety Administration and dissolution of the KFDA has gone abortive. The secretary ge...

6th KORUS FTA meeting scheduled in Korea next month.

In the 5th KORUS FTA meeting in Montana U. S. A. from Dec. 4 to 8 the issue on the drugs made no any concurrence. The medical device and equipment committee had no chances even to discuss in the 5th meeting but p...

KFDA disorganization plans unlikely to happen.

The public hearing over the revised bill of the government organization act covering a new establishment of the Food Administration Agency in separation to the current KFDA seems not to open on Dec. 12 as originally s...

CTD guidelines are available in Korea

The Korea Food and Drug Administration said on December 8 that it has revised a rule for the screening of safety and efficacy of drugs, etc. to introduce for a new common technical document (CTD) guidelines and a fast...

International level of guidelines for herbal drugs under discussion.

An international level of the guidelines for herbal drugs is now under active discussion. The 4th Standing Committee's meeting of the FHH (Forum on Harmonization of Herbal Medicines) in the West Pacific Region of W...

KFDA running task force for bio equivalency test improvement.

To run a task force for the improvement of bio equivalency tests may enhance the credibility of generic drugs. The KFDA said on Dec. 7 that a task force should be organized in an academy and civilian coopera...

Government to exclude insurance-covered drugs for 5 years

The Ministry of Health and Welfare plans to exclude some obsolete drugs from the list of insured medicines, readjust prices of brand-name drugs when their patents expire and re-evaluate how generic drugs are manufactu...

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