What Is Changing — The September Draft Amendment on Quasi-Drug Approval and Review
The Ministry of Food and Drug Safety (MFDS) has issued an administrative notice of a draft amendment to the *Regulation on Product Approval, Notification, and Review of Quasi-Drugs*, with public comments open until September 23. The draft centers on three changes:
Exemption from submitting manufacturing certificates when importing GMP-mandated quasi-drugsRevision of testing items to reflect product-specific characteristicsClarification of the scope of submission documents and review criteriaWhat matters here is the direction: this is less about deregulation than about predictability. Much of the time lost in quasi-drug approvals has come not from the paperwork itself but from ambiguity over how far a given document set must go — a single request for supplementary materials routinely pushes a timeline back by two to three months. Writing the criteria into the regulation narrows that gap.
How Far Does the Certificate Exemption Reach?
Understanding the exact scope is the starting point. The draft limits the exemption to:
Oral liquids and oral solid forms manufactured at GMP-certified facilitiesTopical ointments and cataplasms produced under standard manufacturing criteriaUntil now, importers had to obtain a manufacturing certificate from the overseas facility and have it apostilled or consular-legalized before submission. Depending on the country, issuance through completed legalization takes four to eight weeks, and translation, notarization, and agency fees can run into the millions of won per product. Removing this step can shorten preparation lead time by roughly one to two months.
That said, dosage forms outside the exemption — aerosols, patches, and others — must still be prepared under the existing procedure. The first task, then, is to sort your product portfolio by dosage form and determine which items qualify.
The Opening This Creates for SME Importers
Since the mask and hand sanitizer boom, entry into quasi-drug importing has largely stalled — often because companies gave up at the documentation stage rather than after a market assessment. This amendment lowers precisely that barrier.
Two practical points deserve attention:
Verify the overseas facility's GMP certification status before signing. The exemption hinges on the *status of the manufacturing site*. Concluding a supply agreement without confirming this leaves you following the old procedure in full.Compare domestic contract manufacturing against continued importing. Contract manufacturing offers advantages in supply stability and logistics risk, but carries upfront technology transfer and validation costs. With documentation burden reduced, the break-even point for staying with imports now arrives earlier than before.What the Clarified Scope and Testing Standards Mean in Practice
Your approach to supplementary requests changes. Once items previously subject to reviewer-by-reviewer interpretation are written into the regulation, you can build your dossier against the regulatory text in advance. The shift is from "submit and wait for the deficiency letter" to "build a regulation cross-reference table, close the gaps, then file."Already-approved products need review as well. Once testing items are revised by product type, the specifications and test methods of existing approvals may no longer align. Reconfirm conformity with standard manufacturing criteria and whether a change approval is required.Filing timing becomes a strategic decision. Applications already under review are generally processed under the previous criteria, so withdrawing and refiling is not advisable. For new applications where securing a manufacturing certificate is the bottleneck, however, confirming the effective date and filing afterward may work in your favor.A Checklist for Now, and How KITIM Can Help
Working through the following sequence will let you move as soon as the amendment takes effect:
Classify your products — list them by dosage form (oral liquid, oral solid, ointment, cataplasm, aerosol, patch, and so on)Determine exemption eligibility — confirm whether the item falls under standard manufacturing criteriaCheck overseas facility GMP status — certification, validity period, and inspection historyRun a document gap analysis — build a cross-reference table between the draft regulation and your existing dossierSubmit comments — the comment window closes on September 23, and raising issues specific to your product categories is itself a legitimate response. If you handle dosage forms left out of the exemption, a well-evidenced comment submission is worth considering.KITIM provides regulatory affairs support and quality documentation consulting for quasi-drugs and cosmetics. We assist stage by stage — from product classification and document gap analysis to preparing materials for overseas facility inspections and assessing change approval requirements. If you need a filing strategy aligned with the amended regulation, please reach out through our [consultation request](https://kitim.org/en/contact) page.
