Upgrading of Quality Control for Herbal Medicine Use in South Korea by Introducing an Accreditation System: a brief report.

Abstract

Objectives: This study aimed to present a government-led accreditation system for upgrading the quality control of herbal medicine by introducing the process and evaluation standard of external herbal dispensaries (EHDs) of traditional Korean medicine (TKM) clinics in South Korea 2018 to refer to other countries where herbal medicine were used similarly in Korea.

Development process: We organized an EHD accreditation committee for the establishment of an accreditation system. The committee consisted of 9 experts an official of the Ministry of Health and Welfare (MoHW), a professor expert of TKM, a good manufacturing practice expert, a hazard analysis and critical control point expert, and an accreditation system expert. After 3 meetings, a draft of the evaluation standard and evaluation system was established in 2017. Based on the draft, a pilot test was conducted to determine the applicability of the evaluation standards in 2017. Two additional meeting was held to confirm the accreditation standards and was finalized in 2018.

Results: The evaluation standard for EHDs was developed. In the case of herbal medicine EHDs, the evaluation standard consisted of 9 evaluation categories, 25 evaluation parts, and 81 evaluation items were developed. The results of the evaluation of the pilot tests are as follows, and the results show that there is a deviation between the EHDs.

Conclusion: As a world's first, Korea MoHW successfully launched the accreditation system for upgrading the quality control system of herbal medicine not approved by Korea's Ministry of Food and Drug Safety in 2018. Our report hope to provide a good reference to other countries where having similar herbal medicine system in South Korea hoping to make better quality control of herbal medicines.