News About: Goverment
Standards and process of bridging studies newly to suggest.
The KFDA finally confirmed the assessment guideline for the foreign clinical and bridging study data and the determination of bridging studies.
The bridging study guideline applies to the health registration proces...
Children and elderly patients not exceptional to new medical reform programs.
In the 4th meeting of the Pharmaceutical Affairs Law Revision Subcommittee on Jan. 4 many issues concerning the current medical and pharmacy reform programs did not make any progress, and were deferred to debate again...
Special investigation on prescription related unfair trade practices to strengthen.
To speed up a desirable ground for the government's medical and pharmacy role separation program, the KFDA plans to implement thorough investigations especially against any unfair business collusion between medical in...
Revised bill of pharmaceutical affairs law to debate today at National Assembly.
The Revision Subcommittee for Pharmaceutical affairs law affiliated to the Health and Welfare Committee of the National Assembly scheduled to have the 4th meeting on Dec. 4 to debate the bill raised by the 3 way talks...
Number of products required for bio-equivalency tests to readjust.
The revised pharmaceutical affairs law allows pharmacists to dispense prescription drugs for other substitutive analogues only within the category of biological preparations. Accordingly, the products required for the...
Quasi-drugs to label its prices on package.
According to the regulation titled "The gist of price labelling for cosmetics and quasi-drugs", which was modified from "the gist of price labelling for cosmetics" and will take effect from Jan. 1, next year, all quas...
Social welfare medical service exceptionally applicable to medical and pharmacy role separation syst
The Pharmaceutical Affairs Law Revision Subcommittee of the National Assembly Health and Welfare Committee (Chief: Rep. Yoon Y대-joon) discussed overall revisions of the pharmaceutical affairs law in the 2nd meeting on...
Standards and specifications for medical instruments to be amended.
The KFDA plans to revise the standards and specifications for the medical instruments in order to reinforce the transparency of all processes for the medical instrument's controlling standards and its specifications.
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Medical Insurance price must show on non-prescription drug packages.
An opinion has raised in the recent civil, medical and pharmacy representative's meeting that the medical insurance price shall be indicated on the outer package of all non-prescription drugs, and others complain abou...
Revised bill of pharmaceutical affairs law being hold at National Assembly.
It seems to be difficult for the government's new medical reform program to implement from the early of next year since the current revised bill of the pharmaceutical affairs law is currently kept in holding state at ...
Which are outstanding tetravalent vaccines even for the young?
Disease treated the most with clinical trial drugs is respiratory disorder like lung cancer
Who will be the next Pharmaceutical Safety Bureau Director?
Celltrion completes clinical trials for Remsima SC for European approval
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