News About: Goverment
Government abolishment policy of drug distribution margin opposed by drug industry.
The drug industry strongly opposed against the government policy of eliminating 24.17% traditional hospital distribution margin, which was reflected to the government policy on the medical insurance reimbursement and ...
Basic plan for drug distribution reform to finalize in May.
The MOHW clarified that the basic drug distribution reform plan would be presented to the Distribution Reform Planning Unit (Head: Vice Minister of the MOHW) after due endorsement by the relevant organization and spec...
Multinational drug company rebutted bridging clinical study.
The multinational pharmaceutical corporations strongly resisted against the KFDA's bridging study program recently announced in public, which should be performed only for Korean ethnic patients living in domestic or o...
Professional evaluation organization for bridging study urgently needed.
The KFDA plans to adopt the bridging study system recommended by ICH standards from July 1, this year. In this regard, many opinions are concurred that a special evaluation body should be urgently established for a su...
1.78 multiplication to import landing price desirable for insurance reimbursement.
The imported drug will be reimbursed through the national medical insurance scheme effective from July 1, this year according to the government policy. However, with regard to the reimbursement price determination, Pr...
KFDA drafted revised new drug registration provision.
The KFDA plans to held a public hearing at the auditorium hall of the KPA on April 27 over the revised draft of new drug registration system replacing the current domestic clinical phase III study obligated to a new d...
MOHW may disclose fist price investigation on April 30.
The MOHW took price check for the first time over 60 products including 50 top selling drugs and 10 anthelmintics on April 7 in order to provide drug price informations for consumers, and planned to disclose it on Apr...
KFDA on ultimate stage of revised bill for new drug registration system.
The KFDA has to finalize for the new drug registration system to be ameliorate up to an international standard raised as an international trade issue, which should be competed by the end of coming June to launch it fr...
Medical instrument registration system to be revamped.
In line with the government public administration reform plans the KFDA changed the registration provisions for medical instruments and took effect from April 19, which enables the transfer of product licence to other...
Bulk materials to be registered during approval process for finished drugs.
Having learned from the bitter experience with Ferritin incidence the KFDA plans to intensify drug quality controls over the whole processes from the production and purchasing of bulk materials to the manufacture of f...
