Korea Streamlines Approval for Dual-Formulation Vitamins

The approval and review process for dual-formulation vitamins containing both a liquid and a tablet will be simplified.

The Ministry of Food and Drug Safety announced on the 3rd that it had issued advance administrative notice of a proposed revision to its "Standard Manufacturing Criteria for Pharmaceuticals" notice. The standard manufacturing criteria system standardizes the ingredients, content, and efficacy of over-the-counter drugs whose safety and efficacy have been established, allowing products that meet these criteria to be marketed through simple notification without a separate safety and efficacy review.

The ministry revised the notice to add dual-formulation vitamins containing both a liquid and a tablet to the "Standard Manufacturing Criteria for Vitamins and Similar Products," enabling products that meet consumer preferences to be supplied more quickly. Until now, the standard manufacturing criteria recognized only single formulations such as tablets or liquids, so dual-formulation products required separate approval and review, taking considerable time from product development to launch. The ministry also included in the revision a measure raising the maximum daily dose of vitamin C from 1,500 mg to 2,000 mg.

In addition, the ministry added glycyrrhizic acid to the standard manufacturing criteria for cold medicines, and indomethacin and piroxicam to the standard manufacturing criteria for topical analgesics. It also clarified the criteria for combining live intestinal bacteria ingredients and revised precautions to reflect information such as warnings about severe kidney disease in the use of pseudoephedrine.