"The Ministry of Food and Drug Safety (MFDS) in South Korea has published a casebook providing detailed guidance on the development, consultation, and approval procedures for herbal (natural) medicine preparations. The document supports applicants involved in the development of Investigational Medicinal Products and provides clarification on Regulatory expectations related to safety, efficacy, quality, and clinical trial requirements.
The guidance outlines standards for herbal medicine preparations containing multiple natural ingredients, emphasizing that content standards for each indicator component must be established and submitted, particularly for active ingredients. It also explains expectations for Clinical Trials involving formulation changes, such as modifications from granules to tablets, where additional supporting documents and equivalence data may be required.
Additionally, the document highlights safety and efficacy requirements, including the need for non-clinical studies to use test substances manufactured consistently with future commercial production processes. Comparative equivalence data may also be necessary where manufacturing differences exist. The casebook further explains requirements for Long-Term Storage Studies and the submission of a Stability Test Plan to support the stability evaluation of investigational herbal products. The guidance is presented in a Q&A format to help applicants better understand Regulatory requirements for product approval, quality standards, and clinical development activities related to herbal medicine preparations in South Korea."
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