News About: Goverment
Validation may be established by prospective studies, KFDA says
The validity of systems/equipment/tests/processes may be established and modified by prospective studies under each drug manufacturer's own circumstances, according to the Korea Food and Drug Administration.
With t...
Cost-effectiveness of migraine drugs analyzed
The Health Insurance Review Agency announced on December 26 the results of 11 anti-migraine agents from 41 pharmaceutical firms in terms of cost-effectiveness and clinical efficacy.
In a comprehensive analysis of t...
Professor of Seoul National University becomes NITR headCho Myung-haeng, Seoul National University Professor was named new director of the National Institute of Toxicological Research for the Korea Food and Drug Administration, which...
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KFDA to operate on-line system to support speedy drug license
The development of on-line program, which is aimed at facilitating commercialization efforts of those engaged in the development and research of new medicines, is being mapping out by specialists from government and p...
Rules concerning manufacture of clinical drugs to be eased
The Korea Food and Drug Administration says the rules concerning the manufacturing of biological preparations for clinical use and their quality control would be eased in an attempt to ensure better health of subjects...
KFDA maps out preclinical guidelines on child-specific medicines
The Korea Food and Drug Administration said it will publish its preclinical guidelines on child-specific medicines as more interest has focused on their development in recent years.
We have drawn up the guideline a...
Government to toughen DUR system
The drug utilization review (DUR) system is likely to be further promoted as the government has unveiled its plan to make hospitals and pharmacies install the DUR program in a compulsory manner via down-road from the ...
New schizophrenia drug gets KFDA approval
The Korea Food and Drug Administration (KFDA) has approved Janssen Korea's Invega (paliperidone) extended-release tablets for treatment of schizophrenia.
A similar medication, Risperdal (risperidone), has been ava...
Pricing policy for salt-modified medicines to make public next March
The government plans to establish its pricing criteria for salt-modified drugs on and about next March, according to the Ministry of Health and Welfare.
To that end, the ministry is now under close consultation wit...
Government mulls delay of drug standard barcode system
The Drug Management Information Center said that the Ministry of Health and Welfare is positively considering delaying the planned standardized drug bar-code (KD code) plan after 2009.
A DMIC official said that the...
