The Ministry of Food and Drug Safety said it will streamline the approval process for certain herbal medicines made by extracting and concentrating ingredients from medicinal herbs. Over-the-counter drugs whose dosage forms differ only slightly from already-approved products will be allowed to gain approval without submitting separate equivalence data, under an expanded list of eligible cases.
The ministry said on the 26th that it has issued advance notice of a proposed amendment to the regulation on product approval and notification for herbal medicines, and will take public comments through the 15th of next month.
The core of the amendment is to specify exactly which dosage forms qualify for the exemption from separate equivalence data when an over-the-counter drug differs only marginally from an existing product. Alongside oral solutions and syrups, the extracts and fluid extracts commonly used in herbal medicines will fall into the same category.
The ministry will also establish quality standards that reflect the characteristics of herbal medicines. When an ingredient cannot meet the 99% content threshold because of its inherent properties, as with standard herbal materials, a separate purity standard may be set if valid supporting data is submitted. For solid oral preparations, the amendment makes clear that microbial limit test data must be submitted in accordance with the Korean Pharmacopoeia.
Post-approval change procedures will also be simplified. When only the name of a general test method in the official compendium changes, while the standards and testing methods themselves remain the same, an annual report will suffice without a separate change approval.
The scope for recognizing multiple specifications for the main ingredients of rare-disease drugs will also broaden. Such drugs are currently excluded from the Drug Master File (DMF) registration system, which has limited recognition of multiple specifications, but going forward, multiple specifications may be recognized if quality data comparable to DMF requirements is submitted.
The ministry said it expects the amendment to reflect the characteristics of herbal medicines in approval and review standards and to reduce the data-submission burden on companies.
