News About: Goverment


KFDA intensifies quality of imported drugs before market release.

The KFDA finally established "The basic plan for drug quality control in 1999" and directed it to the regional offices for the purpose of reinforcing the post administrative control on the imported drugs and cosmetics...

MOHW announced revised bill of drug classification standard.

The current provision allows only the manufacturer to change the drug classification from the professional to the general or vice versa. However, in future the pharmaceutical or medical organization are qualified to...

1999 perspective in drug industry: Drug revaluation and PMS

The new drug revaluation system implemented from 1995 seems to be substantially eased and converted to the PMS (Post marketing surveillance) after strengthening the revaluation and the monitoring of drug adverse react...

1999 perspective in drug industry: Enactment of consolidated narcotic law

In line with deregulation reforms the current narcotic law, the psychotropic drug control law and the marijuana control law will be consolidated into "The narcotics and the like control law", eliminating unnecessary r...

1999 perspective in drug industry: Toxicity test standards.

The KFDA, the National Institute of Toxicology revised the toxicity test standards for drug etc. and announced on Dec. 16 in order to meet an appropriate safety evaluation of drugs and other chemical substances in lin...

1999 perspective in drug industry: Bioequivalency test standards.

The KFDA announced the revised provisions concerning the new standards for bioequivalent test containing the extension of qualified institutes of test to all medical institutes and the increased number of test examine...

1999 perspective in drug industry: Revised Medical Affairs Law.

The government prepared the revised draft of the Medical Affairs Law in line with the deregulation and reform plans for the purpose of enhancing efficiency of the medical service for people, and presented it to the He...

KFDA announced revised drug safety information administration act

The KFDA announced to revise the Drug Safety Information Administration Act on Dec. 28, removing the nomination system for specific hospitals and pharmacies as a monitoring institution of drug adverse reactions, and, ...

1999 perspective in drug industry: Open retail price labelling system.

The current standard retail price system is abolished, and instead, the retail price labelling system will be effected from Jan. 1999 after due revision of the relevant provisions. The standard retail price was est...

1999 Perspective in drug industry: Pharmacy facility requirement.

Pharmacy can be established freely without any extra investment for facility and equipment as restricted previously under a certain requirement standard according to the newly revised law. Article 16 and Paragraph ...

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