News About: Goverment
DMF to ward off poor quality bulks.
The DMF system has blocked off an entry of poor quality bulk drugs from China and India.
Mr. Lee Joon-whan, a 5th grade officer of KFDA said in the drug regulatory review meeting on Dec. 22 on the subject of "The b...
Korea gears up for drug license policy overhaul
The Korea Food and Drug Administration said it will gear up to change its drug licensing policy in an effort to provide better support for the domestic drug makers to develop their over-the-counter (OTC) products in a...
FTA trade-offs with U.S. stirs controversy
Seoul's chief negotiator's hint for the Korea-U.S. free trade agreement that Korea could compromise with the U.S. by giving wider access to Korea's auto and pharmaceutical markets if U.S. trade rules are changed is in...
KFDA to introduce fast review system for BT products next year
The Korea Food and Drug Administration unveiled its plan to implement a fast review system from next year to shorten the screening period of biopharmaceutical products' safety and efficacy data from 14 months to 6 mon...
Korea to open oriental medicine market to U.S.
Korea and the U.S. have discussed the issue during negotiations for a free trade agreement (FTA), and the Korean government plans to open the market.
During negotiations, Korea suggested the two nations recognize t...
Korea, U.S. come up with mutual recognition issue only, health ministry says
The Ministry of Health and Welfare hurried to clarify that Korea and the United States have not come up with details about how to acknowledge the licenses, although the countries agreed to allow oriental-medicine doct...
Multi-center clinical studies to reform.
The multi-center clinical studies will be reviewed by the joint IRB, a clinical study review council, which may facilitate far speedy tests.
The KFDA announced the revised standards for clinical test administration...
Mr. Lee Choon-yeop of GSK to name vice president of Handok.
Handok (president: Kim Young-jin) announced that ex-vice president Lee Choon-yeop of GSK Korea was appointed to the vice president of Handok in charge of the sales and marketing activities.
Handok at the same time ...
Pharmacies urged to be alert over contraindicated drugs
Pharmacies will required to confirm a list of contraindicated medicines during dispensing, as the Ministry of Health and Welfare will release a list of such drugs to individual patients, as well as medical institution...
KFDA to reinforce requirements for bio equivalency test institute.
To ensure its credibility of the bio equivalency test results and to trigger an advancement of the institute competence to an international standard, the KFDA intends to request higher levels of requirements for the i...
