Path Cleared for Launch of Dual-Form Vitamins Combining Tablets and Liquid

The Ministry of Food and Drug Safety has established the basis for launching dual-form vitamins in South Korea, with tablet and liquid forms packaged in a single container.

The ministry said on the 6th that it had revised the notification on the “Standard Manufacturing Requirements for Drugs” to include these changes. Under the revision, dual-form vitamins can be launched through notification alone, without separate safety and efficacy reviews. The process has been simplified compared with the previous approval system, reducing the processing period to 10 days.

Dual-form products package liquid and tablets in a single container for simultaneous use. Previously, they required a separate approval process, creating substantial time and cost burdens, but the revision will enable products to be launched more quickly.

The revision also includes regulatory easing related to other over-the-counter drugs in addition to vitamins. Glycyrrhizic acid and mequitazine were added as new active ingredients to the standard manufacturing requirements for cold medicines, while indomethacin and piroxicam were added for topical analgesic and anti-inflammatory drugs.

The maximum daily amounts for some ingredients were also increased. The limit for vitamin C was raised from 1500mg to 2000mg, while the adult limit for chondroitin sulfate sodium increased from 800mg to 900mg. The formulation standard for intestinal bacterial preparations used in digestive medicines was also clarified as “at least one type.”

In addition, precautions for use were added to reflect the latest safety information on active ingredients contained in antipyretic analgesics, cold medicines and oral medicines for rhinitis.

The ministry said, “We will expand consumer choice by promoting the development of a variety of over-the-counter drugs that meet consumer demand,” adding, “We will continue regulatory innovation by reflecting voices from the field in our policies.”