Korea tightens safety regulations on pharmaceuticals

In the wake of the massive recall of a hypertension drug last year, South Korea is stiffening its control of pharmaceutical safety.  Beginning immediately, the country’s primary regulatory body, the Ministry of Food and Drug Safety (MFDS), is mandating manufacturers of raw drug materials disclose any potentially hazardous substances contained in their products while seeking drug approval and registration.

MFDS inspectors will also conduct random inspections of pharmaceutical products and, in the case of drugs manufactured in South Korea,  the physical plants where they are produced. The ministry also plans to revise the Korean Pharmacopoeia, a set of instructions on drug handling for drug manufacturers produced by the government, to meet international standards.

Under the new guidelines, consumers who suffer adverse reactions from the use of pharmaceuticals registered with and approved by the ministry will receive increased compensation.