News About: Goverment
Health ministry to postpone medical law revision
The Ministry of Health and Welfare said on January 30 it decided to delay the announcement of a medical law revision until next week after holding further consultation talks with doctors' groups.
Minister Rhyu Si-m...
Doctors reject new medical law
The Ministry of Health and Welfare's new medical rules, including introduction of a hybrid clinic of Western and Oriental medicines and easing barriers to joining the profession, have faced vehement opposition from th...
38 drug companies to raise class lawsuit on bio test fraud.
The KFDA took the 3rd administrative measure against the drugs, a registration cancellation, on charge of their bio equivalent test fraud, and 38 drug companies related with this problem at once raised a class lawsuit...
Skin softeners, tooth pastes to be classified into quasi-drug
Some OTC products, such as skin softeners, tooth pastes and nicotine-free cigarettes, will be newly designated as a quasi-drug, according to the newly revised law.
In order for customers to freely purchase these it...
GMP for medical device manufacturers required from May.
The good manufacturing practice (GMP) for the medical device industries will be legally required starting from May 31, including the new comers.
The KFDA gave a 3 year probation to the existing medical device manuf...
BGMP-endorsed companies top 129
A total of 129 companies were accredited with BGMP (bulk good manufacturing practice) at the end of last year, according to the Korea Food and Drug Administration.
The BGMP system was made compulsory from 2002 and ...
Approval on GMP and BGMP remarkably shortened to 2 months.
So far the review on GMP and BGMP used to take about 6 months for a final KFDA approval but now it will be shortened to 2 months by administering it by each different product. According to the new regulation, th...
Reductil generic makers to face tougher license procedure
A number of Korean generic makers to develop the generic version of Reductil capsule (sibutramine hydrochloride) will have to pass through more complicated procedures for the approval of their salt-modified compounds....
130 items to benefit from health insurance
A total of 130 drugs, including Bukwang's Lebovir and Hanmi's Liplatin inj. (oxaliplatin) 100 mg will be eligible for health insurance from February 1, the Ministry of Health and Welfare said on January 25.
Besides...
Speedy clinical trials to be available
Clinicians will be able to conduct their clinical trials in a prompt manner with the proposed introduction of a joint institutional review board (IRB), according to the Korea Food and Drug Administration.
To that e...
