News About: Goverment
Courts accepted 14 lawsuits on bio equivalency test manipulation.
Many pharmaceutical companies had filed lawsuits by appealing the KFDA's unacceptable measures connected with the bio equivalency test manipulation scandals but the court rejected the cases related with the prod...
Lawmakers to block passage of KFDA disbandment
The governing and opposition parties and the government are likely to go head-to-head over the controversial disbandment of the Korea Food and Drug Administration (KFDA) at the National Assembly this week.
The gove...
KFDA: other easy ways to prove bio equivalency for drugs.
How to verify the drug equivalency for other products than the tablets and capsules?
The answer is very simple. The liquid forms need only physicochemical equivalency test and the digestive enzyme products require ...
NHI reimbursement contracts unlikely to agree soon.
The NHI payment for the health services has not been accorded among all interested groups but may predict about 3% increases under a unified singular contract.
NHI Policy Review Subcommittee (PRS) discussed a way...
NRC approves new drug pricing policy
The National Reform Committee (NRC) approved on November 23 the government's plan to allow only new and cost-effective drugs to be covered by national health insurance, according to the Ministry of Health and Welfare....
National Assembly members opposed to KFDA shut-down plan.
The Health and Welfare Committee of National Assembly decided to present their opposing opinions to the Ministry of Government Administration and Home Affairs (MOGA) against the revised government bill for the governm...
Government expedites establishment of new food safety agency
The government said it is accelerating its efforts to establish a food safety agency through the separation of the roles of the Korea Food and Drug Administration (KFDA).
A food sanitation agency will be establish...
KFDA suggests quality control standards for clinical sample drugs.
The KFDA will hold a public hearing meeting at the auditorium of Korea Women Development Board on Nov. 27 on the subject of "The quality control standards for the clinical test sample of the investigational new drug (...
KFDA clarifies drug labeling and description issue
In response to a recent civil petition on the labeling and description provisions of drugs, the Korea Food and Drug Administration said that in case of consigning some packaging process to other toll-manufacturing fir...
KFDA seeks to overhaul bioequivalence system
The Korea Food and Drug Administration (KFDA) said recently that the government plans to ameliorate the current bioequivalence system through the enactment of bioequivalence testing requirements, including designation...
