News About: Goverment
GMP to review 172 drug companies without advanced notification.
The KFDA announced to review the GMP for 172 drug companies who were rated at an ordinary grade or lower starting from March 17, especially focusing on their facilities and quality controls.
The rating review was d...
2,600 doctors and pharmacists punished in 5 years.
For 5 years after the implementation of the medical and pharmacy role separation system, about 2,600 medical doctors and pharmacists violated laws and therefore were punished mostly with the administrative measures in...
NHI reimbursement for 191 new products.
Taking effect from April 1, the total 191 drugs including Il Dong's Tomamed 100mg and Hanmi's Topira tab. (all anti-epileptic drug) are newly reimbursable from the NHI scheme, of which the price of 5 drugs rose but 2 ...
Detailed standards for drug small packages until March 31.
The detailed standards for the drug small package supply seems to be settled down before the end of March after extracting an agreement between KPA and KPMA.
The KFDA took the 2nd Drug Small Package Task Force Meet...
KFDA to review data exemption for combined drug registration.
The KFDA said in the brief talk meeting with the pharmaceutical companies of developing a combined anti-diabetic drug that the standards required for the combined drug registration data should be wholly reviewed to an...
907 expensive and frequently prescribing drugs under HIRA controls.
The expensive drug list for the 1Q of drug price review was fixed expecting it to be used for the improvement of physician's prescribing patterns.
The Health Insurnace Review Agency (HIRA) announced the expensive ...
World 7th place of Korean pharmaceuticals by 2015.
The Korean government unveiled a blue print for the pharmaceutical industrial development to put at the world 7th place by brave investments for the R&D and the infra expansion.
The 2nd Pharmaceutical Industrial De...
KFDA to warn against asthma drugs on side effects.
The drug regulatory agency instructed an warning for the medication of asthma drugs such as GSK's Seretide (salmeterol) and formoterol preparations due to adverse reactions reported in the United States.
Taki...
20% of all tablet and capsule drugs to supply PTP packages.
According to a study assigned by the KFDA over the small packaged drug issue, the KFDA seems to follow the suggestion that at least 20% of all tablet and capsule drugs should be supplied in a PTP package and the minim...
KFDA rating drug makers revealed poor GMP management.
The KFDA's drug maker rating report last year showed that "A" and "B" graded companies were only 16 and 17 respectively, indicating not so many outstanding or fair drug makers as expected.
The rating report by dosa...
