News About: Goverment


KFDA to order label change of Janssen Korea contraceptive patch

The U.S. FDA earlier instructed to change the label of Janssen's Evra patch, a contraceptive patch, after warning that it might increase an estrogen exposure to the body. Now KFDA follows the same label change app...

Overseas business for brain ischemic therapy with adult stem cells.

Korea Health Industry Development Institute (KHIDI) recently said that FCB pharmicell, a venture company specialized with adult stem cell research, would export their brain ischemic disease therapy by use of adult ste...

MOHW to set promotional team for Medical Industry Development Commission.

The MOHW plans to launch a promotional team for "Medical Industry Development Commission" for the purpose of promoting the national health insurance related pharmaceutical and medical device industries. The team wi...

Chungang Univ. to hold Bio new drug symposium.

The Molecular Adjustment New Drug Development Institute of Chungang Univ. took the 19th scientific symposium on Dec. 7 on the topic of "Bio new drug development strategy through...

KFDA won the lawsuit implicated with PPA incidences.

About 700 million won of 7 liability lawsuits against the KFDA and the drug makers in charge of the PPA incidences seems to be turned down in favor of the KFDA. At present out of the total 7 lawsuits, 2 cases were...

HIRA to reshuffle its organization.

The Health Insurance Review Agency (HIRA) has segmented the Medical Fees Review Office into more detailed services including drug price analysis and control as well as economical review. The HIRA took a regular di...

Government appointed Mr. Choi as NITR chief commissioner.

The government appointed Mr. Choi Soo-young, ex-Seoul KFDA commissioner, to the chief commissioner of NITR (National Institute of Toxicological Research) as of Dec. 7. He (57...

KFDA to tighten post supervision against human placenta preparations.

A government control on human placenta preparations in the market seems to be tightened with periodical checking on its quality, pharmaceutical supervision at the production plant and obligation to submit the placenta...

KFDA panel to review 9 orphan drugs to resume.

9 orphan drugs including Rilutek (riluzole: Rhone poulenc-Rorer Korea) and Gleevec (Novartis Korea) seem to review their orphan drug positions again. The KFDA planned a Central Pharmaceutical Review Council, Orphan...

MOHW to reject additional penal legislation against rebates.

In the inquiry raised by the Korea Independent Commission against Corruption (KICAC) over the improvement of irregular drug trade practices, the MOHW responded to reject other additional legislation of penalizing the ...

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