News About: Goverment


HIRA to set self-adjustment system for review errors.

The Health Insurance Review Agency set up "Self Correction System for Review Errors" on Aug. 11, which may check any errors of their NHI reviews immediately upon its detection and refund it thereby for the purpose of ...

70% of new drug R&D targeted on natural, bio and modified drugs.

The new drug R&D in Korea targeted to the synthetic chemical compounds by 35%, the natural crude drug by 22%, the modified new drug by 14% and the bio tech product by 29%, showing more weight shift from the synthetic ...

5 new drugs classified to a psychotropic drug.

The MOHW announced on Aug. 8 to revise the drafts for the narcotic control act and its enforcement decree covering that employed pharmacists were also included to the licensed narcotic retailer (Article 2, paragraph 6...

KFDA to specify scope of stability test data for new and generic drugs.

The KFDA Drug Safety Bureau and Drug Review Department announced a unified standard to define the scope of stability test data required for a new and generic drug registration through "Pharmaceutical Regulatory Standa...

MOHW's meeting for drug safety policies on Aug. 18.

A study meeting for the consumer centered drug safety policy was scheduled to hold at the auditorium of KPMA at 3 p.m. on Aug. 18. The MOHW had assigned a study for the subject of a drug safety to minimize any peo...

Data submission simplified for the same preparation with different strengths.

The data to submit for the KFDA registration will be far simplified if the drug be the same dosage form but different strengths, and the domestic clinical study may be restrictively permissible for the use of referenc...

Medical employment must report to HIRA.

The physicians and pharmacists who joined or left the medical institutions shall report to the Health Insurance Review Agency (HIRA) within 15 days according to the relevant provisions, but the personnel movement repo...

Civic group to raise safety problems of Avandia and Adipex

The Korea Pharmacists for Democratic Society (KPDS) claimed on July 27 that despite one year already over with the PPA drug accidents the public health had been threatened because of poor pharmaceutical supervision in...

Massive inspection against illegal medical and pharmacy practices.

A special inspection against the unlawful practices of the medical and pharmacy role separation system seems to undergo for one month long by putting 16 groups of 64 inspectors, the total over 1,000 inspectors during ...

Drug industry and KFDA disputed on DMF postponement.

The DMF (data master file) system in the bulk drug report program was scheduled to implement from coming Sept. 1, but the Korea Pharmaceutical Cooperative Association proposed to the KFDA for a probation period on acc...

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