News About: Goverment
3 Bills to be decided in next National Assembly.
In case of asking expenditure for medicine falsely, revised law of drugs, cosmetics and medical instruments law calls for strong administrational decisions such as cancellation of license, suspension of qualification ...
OECD nations to adopt mutual recognition of GLP
The mutual recognition of GLP (Good Laboratory Practice) system is now under progress of its adoption among OECD nations.
The OECD's meeting of GLP working levels took place in Czech from Dec. 3 to 8 intensively to...
All Bio-related provisions to be consolidated.
The KFDA plans to consolidate all different regulations of ruling the biological preparations into one separate provision to enhance its control efficiency since they all mixed with pharmaceuticals.
The KFDA intend...
Opacity of 3 Bills of Parliament such as Pharmacist Law
The decision of pharmacist revised law in Parliament meeting is opaque as it prepared strong administrational standards like cancellation of license, stopping qualification in case they ask for wrong medicinal bill, b...
KFDA approved compassionate use of Iressa.
The KFDA approved Astra-Zeneca's Iressa, a cancer drug, for a compassionate use in treatment of advanced non cellular lung cancer. Iressa is a new anti-tumor drug still under phase III clinical studies in the United S...
Provisional ban on business collusion substantially to loosen
The provisional restriction on the prescription business collusion acts between medical institutes and pharmacies has been drastically alleviated by reflecting it to the working rules and the enforcement decree of the...
Strengthening Quality Management in Oriental Medicine by Introducing GMP and GSP
The quality management in oriental medicine will be strengthened because of GMP and GSP system, which will be introduced, and every herbal medicine ranging around 514 kinds will be appointed as subject item of standar...
Electro-chemotherapy for cancer patients under clinical trials at local hospitals.
Solco BioMedical Co. recently obtained the KFDA approval for the clinical study project of an electric medical device in cancer treatments, and made study contracts with Banjigeo hospital and Kangreung Dongin hospital...
Clinical Evaluation Standard for Hepatitis Remedy, etc Presented.
Clinical evaluation standard for medical effects of three remedies such as anti-virus and second type of diabetes was presented.
The clinical evaluation policy for 3 medical effects prepared by Korea Food and Drug...
DMF system initially to apply for antibiotics.
Taking effects from the next year the bulk materials of antibiotics and biological preparations should be registered for use in Korea, and the bulk manufacturing company required the BGMP approval from the KFDA until ...
