News About: Goverment


Bufexamac-containing medicines to be banned

The Korea Food and Drug Administration (KFDA) said on December 8 it has decided to ban sales of controversial bufexamac-based drugs, because of high risk of contact allergies. Bufexamac is a non-steroidal anti-infl...

Government to seek deregulation in services

The government announced Tuesday that it will lower the entry barriers to the communication/education, energy, medical/pharmaceutical and other professional services markets from the first half of next year. Indust...

Functional food makers caught for exaggerated ads

Many people could be attracted to buy nutrients capsules if they were said to prevent cancer, control blood pressure or show other amazing medical effects. However, the Korea Food and Drug Administration (KFDA) war...

New DMF system likely to be delayed

The Korea Food and Drug Administration is considering delaying the new DMF (drug master file) system at the request of the industry. Under the planned DMF system to take effect from next January, a local drug manuf...

Detailed screening guideline on combination product makes public

The detailed screening rules on the license application of generic combination products have been disclosed recently. In an information session on December 3, officials at the Korea Food and Drug Administration pro...

Small- and medium-sized wholesalers to introduce credit card system

Influenced by the recent drug pricing reform, small- and medium-size wholesalers are set to change its settlement method from cash to credit card. These wholesalers said that each time pharmacists use their credit ...

KFDA to upgrade DMF system

The Korea Food and Drug Administration today holds its information session over the implementation of the newly revised DMF (drug master file) system, under which local drug manufacturers and/or importers are obliged ...

30 medical device makers fined for unfair practices

Local manufacturers and distributors of medical device, who were found to give kickbacks to doctors and hospitals, have been fined, it was reported recently. The National Tax Service (NTS) said that it imposed a co...

Drugmakers skeptical over off-label drug use

Why is the majority of Korean pharmaceutical firms shying away from off-label use that that would benefit them? "Off-label" means the medication is being used in a manner not specified in the KFDA's approved packag...

KFDA to set up new guideline for selection of control drug

The Korea Food and Drug Administration plans to draft a new guideline for control drugs used in bioequivalence testing, dissolution testing and physiochemical testing as part of efforts to clarify the selection criter...

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