News About: Goverment
No bio-equivalency test required drugs to be announced soon
The KFDA's delayed announcement of drugs that are not required for the bio-equivalent test hampers the substituted dispensing activities at pharmacies.
The exempted items for the bio-equivalent test included oral...
40 substances subject to standard protocol for bioequivalence tests designated
The Toxicology Research Institute (TRI) of the Korea Food and Drug Administration announced that of a total of 52 ingredients for the standard protocol of bioequivalence tests, 40 ingredients was designated and one or...
Problems involved in separation of drug dispensing from medical practice analyzed
Pharmaceutical industry sources say that the current system of separating drug dispensing from medical practices (SDP function) still needs to be further ameliorated due to the following adverse factors, even since it...
MOHW to extend the treatment days in patients with 11 chronic diseases
The Ministry of Health and Welfare announced it has finally designated 11 chronic diseases whose treatment days can be exceptionally extended over 365 days from the current insurance-covered days. The current notice a...
MOHW's inconsistent drug related policy triggers the mounting discontent
Pharmaceutical industry sources say that the inconsistent drug-related policy of the Ministry of Health and Welfare (MOHW) has rekindled a severe opposition from the domestic pharmaceutical industry, over the MOHW's p...
Mandatory implementation of bioequivalence test in drug license eyed
The Korea Food and Drug Administration (KFDA) says it will draft a series of drug-related measures relating to more expanded implementation of bioequivalence test during drug license and re-evaluation on drug necessit...
Tonic drink for patients permitted to sell at pharmacies.
The MOHW interpreted it as lawful for pharmacies to sell tonic drinks to patients who are awaiting for the prescription filling when a civilian raised the question. The MOHW said that the pharmacy may provide a conven...
NHI price inspection proceeded unprincipled.
Many opinions claimed that the post supervisory activities conducted periodically by the MOHW, the KFDA and the HIRA especially over the NHI drug pricing in the markets showed unprincipled, causing a lot of disadvanta...
Non-insurance drugs to be included in prescription records
In response to a recently raised question on the dispensing records of prescription by a regional chapter of the Korea Pharmaceutical Association, the Ministry of Health Welfare (MOHW) explained that a pharmacist shou...
Special inspection on vaccine manufacturers.
The KFDA plans to take a special inspection over 6 vaccine manufacturers producing Japanese encephalitis virus vaccine and DPT mainly focusing on the GMP compliance to the biological preparations and other compliances...
