--- title: The Maker Only Provides an Ingredient List, How Is the Rest of the PIF Completed author: Pharmacist Hsiao-Chen lang: en canonical: https://www.pharmachen.com/pif/en/importer/maker-provides-ingredients-we-complete/ published: 2026-08-25 --- # The Maker Only Provides an Ingredient List, How Is the Rest of the PIF Completed **Bottom lineļ¼š** The Japanese maker only needs to provide the complete ingredient list with concentration ratios; the Taiwan-side professional process then completes physicochemical properties, toxicological support, and SA signing. The maker need not become a Taiwan regulatory expert. ## The maker's biggest blocker is not knowing what Taiwan wants The Japanese maker is unfamiliar with TFDA format, unsure how to prepare toxicological support, and cannot find a Taiwan SA, so they "want to comply but don't know where to start," and the case stalls. But the maker only needs to provide one thing: the complete ingredient list with concentration ratios, data the maker already has from making the product. ## After the Taiwan side takes over, three things First, organize physicochemical properties from the ingredients into compliant content. Second, complete toxicological support using EU-recognized scientific methods aligned with Taiwan's TFDA rules, replacing unnecessary repeat experiments with existing scientific data where conditions permit. Third, a qualified SA completes and signs a legally effective safety assessment report based on margin-of-safety calculation. With these three done, a usable PIF holds up. The maker supplies the ingredient list; the Taiwan side completes professional assessment. The division is clear. ## Platformization turns months into days Previously done by hand item by item, it was slow. Now this judgment and organization can be accelerated by system: AI helps parse the ingredient list, auto-generates physicochemical and toxicological structure, and an SA does final oversight and signing. A process once measured in months compresses to days. Faster doesn't mean cutting corners; it means removing repetitive work by system and reserving expertise for what truly requires judgment. ## FAQ ### What must the Japanese maker provide for the PIF to start? Most critically, the complete ingredient list with concentration ratios. With it, the Taiwan-side process can take over and complete the rest. ### Does the maker need to understand Taiwan regulations? No. The maker only provides the ingredient list; physicochemical properties, toxicological support, and SA signing are completed on the Taiwan side. The maker need not become a Taiwan regulatory expert. ### What items does the Taiwan side complete? Physicochemical properties, ingredient toxicological support, and the safety assessment report signed by a qualified SA, the three items beyond maker data that most require professional completion. ### How long does the whole process take? With system acceleration, a process once in months can compress to days, though actual timing depends on ingredient complexity and missing materials. --- https://www.pharmachen.com/pif/en/importer/maker-provides-ingredients-we-complete/