News About: Goverment
Individual pill packs must show drug names and shelf life.
Starting from the 2nd half of next year at the earliest it obligates for the individual pill package to show the name of its maker or importer, the lot number, expiry date or shelf life. The same shelf life descriptio...
GMP validation soon applicable to each drug item.
Instead of abolishing a packaged GMP recognition system for 6 major dosage formed preparations, the KFDA will adopt the post GMP supervision system by each item by means of applying the GMP validation in the future, t...
New HIRA president pledges to reinforce national health insurance systemNew Health Insurance Review Agency President Chang-yup Kim pledges to enhance efficient and qualitative health care services in the National Health Insurance.
In an press int...
|
Lawmaker seeks to separate manufacturing license from product license
Rep. Moon Byung-ho said he is considering submitting a reform bill within this month to separate a manufacturing license from a product license in order to ensure an earlier commercialization of biodrugs.
Under the...
More than 100 of KFDA drug registration reviews being disclosed.
The disclosure policy of the new drug registration review outcomes has been implemented since 2004, which was recently more accelerated, expecting to give a lot of helps for the drug makers to get the same registratio...
KFDA review supplementation extended to 10 days from 7 days.
The terms for the supplementing the documentations especially on the standards and assay methods will be extended now from 7 days to 10 days, and the postponement of the supplementing terms can be extended twice in th...
Oriental graduated medical school to establish in 2008.
The government decided in the relevant ministerial meeting to establish an oriental graduate medical school some time in 2008, for which nobody knows which university it puts in. Originally, the government was about t...
Gradual recognition plans for licences in the KORUS FTA.
In the extraordinary session of National Assembly on July 26 the MOHW answered to the question raised by Rep. Lee Ki-woo about the health and medical policy for the KORUS FTA talks that the reciprocal recognition of t...
Drug registration system to be substantially reshuffled from Oct. 1.
The health registration system for drugs will be radically reshuffled from coming Oct. 1 according to the KFDA.
For this objective the KFDA already disclosed a draft of the revised registration provisions for manuf...
National Assembly Ad hoc panel on FTA with US convened
A National Assembly ad hoc panel on free trade talks with the United States convened on July 31, officials at the Assembly's secretariat said.
Composed of 20 lawmakers, the ad hoc panel is aimed at formulating meas...
