Korea Institutes New Drug Regulations to Boost Safety, Speed Approval of Much Needed Rare Disease Treatments

Major new safety regulations set to take effect in South Korea in August include priority screening of biopharmaceuticals designed to treat rare diseases, The new safety regulations, instituted in the wake of a series of pharmaceutical safety scares, for the first time separate the management of biopharmaceuticals and regenerative medicines from that of existing generic drugs. They are designed to tighten South Korea’s control of pharmaceutical safety following massive recalls of valsartan, a blood pressure drug, and peptic ulcer drugs ranitidine and nizatidine drugs in 2018 and 2019, when each was found to contain a potentially carcinogenic impurity. In December the same substance was found in widely used diabetes medications containing metformin.

The new regulations mandate a step-by-step preliminary screening of the drugs, but also provide a pathway to rapid approval of some needed urgently by patients. The new screening processes are expected to increase safety but also expedite drug development.