Taiwan's Phased Cosmetic GMP Rollout: The Three-Phase Timeline and What Brand Owners Should Do
Taiwan's cosmetic GMP was rolled out in three phases, and all three phases, effective July 1, 2024, July 1, 2025 and July 1, 2026, are now in force. Except for solid handmade soap makers exempt from factory registration, every cosmetic manufacturing site must now comply with the Cosmetics Good Manufacturing Practice Regulations (化粧品優良製造準則). For brand owners, the question is no longer whether to prepare, but whether your manufacturer complies today and can prove it.
Key takeaways
The three-phase timeline and product scope
According to the Ministry of Health and Welfare, cosmetic manufacturing sites had to comply with GMP on the following schedule:
| Phase | Effective date | Manufacturing sites covered | Examples | Status |
|---|---|---|---|---|
| Phase 1 | July 1, 2024 | Sites making specific-purpose cosmetics | Sunscreens, hair dyes, perms, antiperspirants/deodorants, home-use tooth whitening products | In force |
| Phase 2 | July 1, 2025 | Sites making baby, lip and eye cosmetics and non-medicated toothpaste and mouthwash | Baby wipes, lipsticks, lip masks, eyeshadows, eyebrow pencils, non-medicated toothpaste and mouthwash | In force |
| Phase 3 | July 1, 2026 | All other general cosmetic manufacturing sites (except solid handmade soap makers exempt from factory registration) | Toners, serums, creams, sheet masks, shampoos and body washes | In force |
The Product Information File (PIF) requirement follows the same three-phase schedule, so a cosmetic sold in Taiwan today must be made at a GMP-compliant site and must have a PIF. See the PIF guide for what to prepare.
History: from voluntary certification to a legal requirement
| When | What happened |
|---|---|
| From 2008 | TFDA and the Industrial Development Bureau of the Ministry of Economic Affairs jointly ran a voluntary GMP certification scheme for cosmetic factories |
| 2014 | The two ministries revised the voluntary GMP guidelines, adopting the national standard CNS 22716 as the basis for certification |
| May 2, 2018 | The Cosmetic Hygiene and Safety Act was promulgated; Article 8 requires manufacturing sites for designated categories to comply with the GMP regulations |
| July 1, 2019 | The Act took effect; the Cosmetics Good Manufacturing Practice Regulations, based on ISO 22716, were issued in August of the same year |
| 2024 to 2026 | The three phases took effect, bringing all cosmetic manufacturing sites under GMP |
The competent authority is the Ministry of Health and Welfare, with day-to-day work handled by the Taiwan Food and Drug Administration (TFDA). The former Department of Health under the Executive Yuan was reorganized into the Ministry of Health and Welfare in 2013.
What the new system means for brand owners
GMP applies to manufacturing sites. If you work with a contract manufacturer, the impact shows up in three places:
- Your manufacturer must comply with GMP: A non-compliant site cannot legally manufacture cosmetics. If a manufacturer is found non-compliant and fails to correct it within the deadline, it may be fined and, in serious cases, suspended, which would also affect your production schedule.
- The contract relationship must be in writing: The GMP regulations require the contract giver and contract acceptor to sign a written contract defining their responsibilities, and the acceptor may not subcontract without consent.
- Your PIF relies on GMP records: The manufacturing method, quality specifications and batch test data in a PIF all come from the manufacturer's GMP documentation.
For an element-by-element explanation of what the GMP regulations require, see the 14 core elements of Taiwan cosmetic GMP.
What brand owners should confirm now
| What to confirm | How |
|---|---|
| Whether the manufacturer has passed GMP | Check the list of sites that have passed the cosmetic GMP compliance inspection in TFDA's Cosmetic GMP section |
| Whether its product forms cover your product | The "product forms" (劑型) column, e.g. liquids, emulsions, oils, powders |
| That it is the actual manufacturing site | The "operations" (作業項目) column should include manufacturing, and the address should be the factory making your product |
| Validity date | The "validity date" (有效日期) column; check it will not expire during your launch period |
| Contract responsibilities | Whether the manufacturing agreement defines responsibility for quality, complaints, recalls and documents |
| PIF and product notification | Who builds the PIF and which manufacturing and quality data the manufacturer will provide |
Beyond GMP, also compare R&D, communication and regulatory document support. See how to choose a cosmetic manufacturer in Taiwan.
FAQ
Q: Do products launched before the new system need to be handled again?
GMP is a requirement on the manufacturing site, not on the launch date. As long as a product is still being produced, its manufacturing site must comply with GMP, and the product must have a PIF in line with the schedule. Confirm with your manufacturer that the production site is on TFDA's list and that you can obtain the manufacturing and quality data needed for the PIF.
Q: Are solid handmade soaps completely unregulated?
No. Solid handmade soap makers exempt from factory registration are outside the scope of GMP Phase 3, but their products are still subject to product notification, labeling and other rules under the Cosmetic Hygiene and Safety Act. For the conditions of the factory registration exemption, see key points of Taiwan's Cosmetic Hygiene and Safety Act.
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