Korea's food and drug safety ministry to supply 882 reference materials from Oct. 12

The food and drug safety ministry said it will begin distributing 882 reference materials for drug quality testing from Oct. 12, including 24 new items and the agency's first internationally certified standards.

The 2026 standard materials guide, published by the ministry's National Institute of Food and Drug Safety Evaluation, lists reference materials across pharmaceuticals, biopharmaceuticals, herbal medicines and in vitro diagnostic medical devices. Two of the newly supplied items are dl-methyl Ephedrine hydrochloride and tipepidine citrate, produced under the institute's ISO 17034 accreditation as a certified reference material producer, which it obtained in June 2026.

The ministry is also supplying reference materials for nitrosamine impurities for the first time, including NDMA, or N-nitrosodimethylamine. Nitrosamines can form unintentionally during the manufacturing and storage of medicines, and the ministry has said they require thorough management.

"We expect that this expansion of standard material supply will help the pharmaceutical industry reduce its dependence on overseas standard materials and stably secure the materials it needs," the ministry said. "The supply of certified reference materials will serve as an opportunity to raise the reliability of testing and inspection of medical products and quality management capabilities."

The ministry said it plans to continue developing and supplying high-quality standard materials reflecting demand from industry.

The guide can be viewed on the National Institute of Food and Drug Safety Evaluation website under electronic civil services, standard materials and standard materials by field.