Food and drug safety ministry simplifies herbal drug approval data

The food and drug safety ministry said it will streamline submission requirements for approving herbal and crude drug preparations, a move officials said is designed to reflect the specific characteristics of these drugs and improve convenience for applicants.

Proposed revisions explicitly define dosage forms exempt from submitting equivalence data when differences from existing approved items are minor, adding extracts and fluid extracts alongside oral solutions and syrups for over-the-counter medications. "We expect these measures to rationalize the scope of data required for approval applications," the ministry said in a statement announcing the administrative preview.

The amendments also allow exceptions to standard purity criteria for herbal ingredients where meeting the typical 99 percent threshold is difficult, provided valid supporting data is submitted. Solid preparations must undergo microbiological limit testing in accordance with the Korean Pharmacopoeia, while manufacturing process changes that only involve renaming general test methods without altering standards will require only an annual report instead of full change approval. Additionally, the scope for accepting multiple specifications of active ingredients will expand to include rare drugs, which were previously excluded from drug master file registration equivalents.

The ministry will accept public comments on the draft amendments through Sept. 15.