한의약품 제조규제의 강화 - 미국 최초 식품의약법상 의약품규제의 시사점 -

Most of pharmaceuticals, dissimilar to foods, have poison in a certain degree. When someone takes wrong-made pharmaceuticals or makes a mistake in taking them, they can be very harmful to his health. Korean traditional drugs can have poisons, but nevertheless, they have been sold by korean oriental doctor without making permission prior to marketing them. Korean Supreme Court decided recently, “korean traditional drugs can do damage to one’s health by them alone or with western drugs which patients take”, in the case, that sugar diabetes patient took a korean traditional drug, and suffered injury of liver.(Korean Supreme Court decision 2009 Da 102209 Delivered on October 13, 2011)This decision has a huge historical meaning, that the Korean Supreme Court admitted, some of korean traditional drugs have liver damaging effect. Korean traditional drugs must be scientifically tested about their safety and efficacy prior to selling them in the market. U.S. Federal Food and Drugs act of 1906 regulated adulteration and misbranding as criteria for prohibition of drug making and marketing. The act enacted a provision about the drug formulary, and tried to protect homogeneity of drugs. Korean traditional drug formulary is very old-fashioned, and too short to protect safety and efficacy of korean traditional drugs. The formulary is too short of explanation about components of drugs, and does not include explanation about side effect of drugs. Korean National Assembly must introduce scientific regulation of traditional drug making, and modernize korean traditional drug formulary.