News About: Goverment
DMF Requirements Clarified by KFDA
The Korea Food and Drug Administration (KFDA) recently provided a set of specific details surrounding the Drug Master File (DMF) requirements, under its effort to implement the Pharmaceutical Bulk Report System schedu...
Current List of Medical Narcotics To Be Expanded
The Ministry and Health and Welfare (MOHW) submitted a regulatory revision draft on January 14th to expand the current list of medical narcotics that are under restrictive control by the government, and to include a s...
Domestic CROs Performed 233 Contract Bioequivalence Tests in 2004
It is determined that the domestic contract research organizations (CROs) conducted a total of 233 instances of contract-based bioequivalence tests during last year, with Biocore Corp. and LabFrontier Co. Ltd. showing...
Total Size of Domestic BT Sector Estimated at 3.36 Trillion Won for Year 2005
It is estimated that the total size of domestic biotechnology sector for Year 2005 will be around 3.36 trillion won, up 12% from the prior year.
According to Director Kim Moon-ki of the Bioindustry Association of ...
Licensed Post-Production Neutraceutical Administrator SuggestedFrom the January 12th weekly discussion meeting held at the Korea Food and Drug Administration (KFDA), Professor Park Ki-whan of Chung-Ang University College of Industrial Scien...
|
4,873 Items Subject to Drug Re-Evaluation Reviews
The Korea Food and Drug Administration (KFDA) has released the list of pharmaceutical items subject to this year's re-evaluation reviews on 4,873 items from 4 therapeutic groups with 21 subcategories.
Of the total...
Clozaril Now Covered by National Health Insurance
Following the last year's approval by the Korea Food and Drug Administration (KFDA) on the additional indication of Clozaril (active ingredient: clozapine) to reduce risk of suicidal behavior in patients with schizoph...
Serious Adverse Effect of Benzbromarone Re-Emphasized
The Korea Food and Drug Administration (KFDA) recently released an advisory letter addressed to the healthcare professionals on the reported mortality instances in Japan by medications containing benzbromarone, which ...
Government Permits 17 Domestic Human Tissue Banks
The Korea Food and Drug Administration (KFDA) gave its final approvals on January 7th of the operational permits to 17 domestic human tissue banks, in an effort to promote the activities surrounding the human tissue d...
KFDA Concentrates on Top 300 Pharmaceutical Items for Quality Inspection
Under an initiative to conduct quality inspections on 2,000 pharmaceutical items for the current year, the Korea Food and Drug Administration (KFDA) announced it would concentrate on the top 300 items, in terms of the...
