Accreditation system for external herbal dispensaries: world’s first quality control on the government level

 

Leading for the establishment of a safety management system for Herbal Medicine (Pharmacopuncture)

Accreditation system for external herbal dispensaries: world’s first quality control on the government level
(Quality control of Herbal Medicine)

 

Introduction of accreditation system for external herbal dispensaries

The Ministry of Health and Welfare introduced the accreditation system for external herbal dispensaries in April 2017 to enhance the safety of pharmacopuncture and Herbal Medicine manufactured at external dispensaries.

 <Accreditation mark of external dispensary> 

Current status of external herbal dispensaries across the country An “external herbal dispensary” is governed under ‘Medical Service Act Enforcement Regulation’ attachment 3. It is defined as a facility making Herbal Medicine like decoction, pill and paste in accordance with prescriptions by Korean Medicine doctors, established separately outside of medical institutions. There are around 100 facilities throughout the country as of 2019.

 

Granting Ministry of Health and Welfare’s accreditation to 7 external herbal dispensaries

As of April 2020, a total of 7 external herbal dispensaries have been accredited by the Ministry of Health and Welfare. Among those 7 accredited dispensaries, 3 are for pharmacopuncture and 4 are for general Herbal Medicine production. The list of accredited external herbal dispensaries can be verified on the website of the Ministry of Health and Welfare and the National Institute for Korean Medicine Development.

 

Assessing all processes from raw material warehousing at dispensaries to storage, production, packaging, and delivery

There are two types of accreditation system for external herbal dispensaries. intone for “dispensaries for general Herbal Medicine production” and another for “dispensaries for pharmacopuncture.”. General Herbal Medicines refers to various Herbal Medicine dosage (decoction, pill, discutient, paste, capsule and tablet). They are assessed by 139 criteria items (81 regular and 58 recommended items) reflecting KGMP* and HACCP** criteria, including whether to use standardized medicinal herbs completing safety inspections such as heavy metal, pesticide residue tests, etc. “Pharmacopuncture” is assessed by 218 criteria items (165 regular and 53 recommended items), including items related to KGMP like the clean zone setup, environmental management and sterilization process.

* KGMP(Korea Good Manufacturing Practice)

** HACCP(Hazard Analysis and Critical Control

 

Introduction of accreditation system for external herbal dispensaries, its meaning and way forward

The accreditation system for external herbal dispensaries is the world’s first quality control regulation introduced at the governmental level. to Herbal Medicines (pharmacopuncture). The system also describes management standards for the overall preparation process at the external herbal dispensary, including what facilities and environment must be installed to manufacture safe and clean Herbal Medicines and pharmacopuncture and how to appropriately manage documentation and prescription processes.

 Therefore, it is significant that a baseline criterion was established to produce safe Herbal Medicines (pharmacopuncture) through accreditation assessment or its own quality control at the external herbal dispensary, an area that had been in operation without separate management criteria. At present, 7 external herbal dispensaries have been accredited by the Ministry of Health and Welfare, accounting for 7% of the country’s total. At present, 7 external herbal dispensaries have been accredited by the Ministry of Health and Welfare, accounting for 7% of the country’s total. To establish a safer management system for Herbal Medicines (pharmacopuncture), more external herbal dispensaries should be accredited and managed in the institutionalized system. The National Institute for Korean Medicine Development will make its best effort to ensure that the public can take Herbal Medicines and receive pharmacopuncture safely by creating a management system in which safe Herbal Medicine and pharmacopuncture are offered through the continuous accreditation assessment of external herbal dispensaries.

 

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