News About: Goverment
Even combined prescription drugs require equivalency test.
The KFDA disclosed two revised drafts of regulations named "The Drug Equivalency Test Regulation" and "The Bio-Equivalency Test Standard" on Sept. 3, covering that even combined prescription drugs require the equivale...
New KFDA head emphasized registration system for competitiveness.
Chief commissioner Kim Chung-sook of KFDA stated that the pharmaceutical registration system should be improved to enhance the competitiveness of the pharmaceutical industry that had been adopted as one of the nationa...
No safety problem on drugs containing poison and deleterious substances.
In responding to the recent controversy raised by the press over the safety problems on the non-prescription GI drug containing a poisonous and deleterious ingredient the MOHW confirmed no safety problems at all since...
Kim Jung-sook to head Korea Food and Drug AdministrationPresident Roh Moo-hyun on September 1st appointed senior researcher of the Korea Institute of Oriental Medicine Kim Jung Sook as a new commissioner of the Korea Food and Drug Ad...
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Positive list system on reimbursable drugs recommended
The current negative list system of reimbursable drugs should be changed into the positive list system in the mid- and long-term, as part of undertaking the effective management of drug costs in the nation's healthcar...
MOHW to establish Drug Safety Policy Review Council.
The MOHW set up Drug Safety Policy Review Council for the objectives of keeping a sustained information and review on drug safety, thereby protecting the people from any possible drug adverse reactions and enabling th...
KFDA urge to insert 'precaution in use' in public drug advertisement
The Korea Food and Drug Administration said on August 30 that it has called on the Korea Pharmaceutical Manufacturers Association not to delete the current phrase 'precaution in use' in the public drug advertisements ...
Domestic drug makers' rush to antihypertensive and antidiabetic drugs market
Stimulated by the government policy to provide preferential treatment for generic and bioequivalence-tested drugs, a number of drug makers are rushing to introduce generic versions of Pfizer's Novarsc and Handok Pharm...
New drug pricing policy linked with price and volume.
The future drug pricing policy may link with its price and prescribing volume and the already registered drugs will be reclassified in consideration with its therapeutic efficacies.
Based on their study outcomes fo...
Applications for bioequivalence testing top 325
The Korea Food and Drug Administration said that for the first seven months of this year, accumulated applications for bioequivalence testing totaled 325, which more than doubled over the same period of last year.
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