Improvement of Collaborative Decoction Facility Certification System... "Enhancing Safety in Herbal Medicine Preparation"

Ministry of Health and Welfare Revises Certification Standards for Collaborative Decoction Facilities, Effective Through 2029

Stricter Herbal Acupuncture Preparation Standards and Streamlined Administrative Procedures

The Ministry of Health and Welfare announced on March 26 that it has newly established evaluation and certification standards for collaborative herbal medicine decoction facilities (external decoction facilities) specializing in the preparation of herbal medicines.

The certification system for collaborative decoction facilities is a system that evaluates the facilities, operations, and overall preparation processes of decoction rooms to enhance the safety and reliability of herbal medicines. To date, 25 out of 127 collaborative decoction facilities nationwide (8 for herbal acupuncture preparation and 17 for general herbal medicine preparation) have received certification. The certification system evaluates facilities separately as "herbal acupuncture preparation decoction facilities" and "general herbal medicine preparation decoction facilities."

The new certification standards were finalized through a task force consisting of experts in each field, after gathering opinions and discussions from the industry, and a review and resolution by the Collaborative Decoction Facility Evaluation and Certification Committee. The main features include raising the certification standards for herbal acupuncture preparation to strengthen the safety of herbal medicines and streamlining administrative procedures to reduce the work burden on decoction facilities subject to evaluation.

The key revisions include: ▲ introduction of a performance qualification assessment for collaborative decoction facilities preparing herbal acupuncture; ▲ changing the name from "external decoction facility" certification to "collaborative decoction facility" certification; ▲ shortening the minimum operation period required to apply for certification; ▲ establishing exemption criteria for interim evaluations for outstanding institutions; and ▲ removing regulations for unannounced inspections of small-scale collaborative decoction facilities certified for general herbal medicine preparation.

Park Jonguk, Director of the Department of Korean Medicine Industry at the Ministry of Health and Welfare, stated, "We will work to strengthen the safety of herbal medicine preparation, including herbal acupuncture, and activate the evaluation and certification system, thereby enhancing public trust in Korean medicine and contributing to public health."

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