News About: Goverment
KFDA to rate pharmaceutical company by drug adverse reports.
In an attempt to activate the drug adverse report activities at all concerned authorities, the KFDA announced on April 25 that the relevant health agencies should collect drug adverse reaction reports on quarterly bas...
KFDA needs enough officers for bio equivalency test administration
Rep. Moon Hee of the opposition Grand National Party said that the KFDA had only 7 responsible officers for the drug bio equivalency test and the test review took roughly 2
months, indicating a need of more manpower...
KFDA no excluded drug makers on test manipulation scandal.
The KFDA reported 4 test institutes related with the fraudulent bio equivalency test such as Lab Frontier, KPTA Bio Test Center, Bio Core and Sunkyunkwang Univ. to the public prosecutor but did not decide a similar pr...
Civic group blames MOHW/KFDA for manipulated test scandals.
The Health Right Network, a civic group for the people's health, released an official statement on April 26 against the bio equivalency test manipulation scandal, saying that the bio equivalency test manipulation inci...
No NHI reimbursable for 10 drugs of bio equivalency test scandals.
The MOHW said that 10 drugs complicated with the bio equivalency test manipulation would be deleted from the NHI reimbursement schedule taking effects from April 25.
10 drugs include Fosanex 70mg tab., Kolon Alrend...
KFDA notifies 182 substitutive drugs to KPA.
9 products including Alend 70mg tab. were earlier suspended to reimburse by the NHI scheme due to the bio equivalency test fabrication, for which, instead, the KFDA sent an official notification to the Korea Pharmaceu...
4 institutes including Labfrontier manipulated tests on 10 products.
The KFDA released the investigation report covering that a majority of bio equivalency test institutes committed fraudulent tests on 43 products out of the total 101 investigated drugs. Some of cases were already pros...
Drug registration without paper documentations, calls and contacts.
Very soon, maybe a few months later, all pharmaceutical health registrations seem to be proceeded without any paper documentations, personal calls and contacts, which will be then a revolutional reform in the pharmace...
KFDA instantly to disclose bio equivalency test fraud.
Director Moon Byeong-woo, the Drug Safety Division head of KFDA is going to disclose instantly the interim investigations on the manipulated bio equivalency tests at the KFDA briefing room at 10 a.m. on April 25.
I...
Administrative measures on PMS breaching and poor drug quality.
The KFDA administrative measure report in 2005 revealed that most of the cases imposed to 32 drug companies including Yuhan, Bayer Korea, Roche Korea and Shinpoong were mainly on charge of the PMS (post market surveil...
