On March 3, 2026, the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare issued Announcement No. 1151400412, amending the "Processing Timeframe Table for Application Items." This announcement covers pharmaceuticals, food, medical devices, cosmetics, and other fields, specifying processing timeframes for various matters. It includes 11 items related to cosmetic management and 12 items related to cosmetic manufacturing site management and laboratory accreditation.
Revision Content
Cosmetic Management Category
| No. | Application Item | Processing Period (Days) | Legal Basis | Key Work Stages | Processing Days |
| 1 | Domestic/Imported Medicinal Cosmetic Registration Application | 90 days | Cosmetic Hygiene Management Act | Initial Review | 50 days |
| Post-Supplement Review | 40 days | ||||
| 2 | Domestic/Imported New Medicinal Cosmetic Registration Application | 150 days | Cosmetic Hygiene Management Act | Initial Review | 50 days |
| Post-Supplement Review | 40 days | ||||
| Consultation Meeting Review | 60 days | ||||
| 3 | Domestic/Imported Medicinal Cosmetic License Amendment (1) - Ingredients, Manufacturer, Additional Items, etc. |
60 days | Cosmetic Hygiene Management Act | Initial Review | 40 days |
| Post-Supplement Review and System Entry | 20 days | ||||
| Domestic/Imported Medicinal Cosmetic License Amendment (2) - Product Name, Packaging, and Other Amendments |
30 days |
Cosmetic Hygiene Management Act |
Initial Review | 20 days | |
| Post-Supplement Review and System Entry | 10 days | ||||
| 4 | Domestic/Imported Medicinal Cosmetic License Cancellation | 7 days |
Cosmetic Hygiene Management Act |
Review and Verification | 6 days |
| System Entry | 1 days | ||||
| 5 | Domestic/Imported Medicinal Cosmetic License Reissue for Loss | 15 days | Cosmetic Hygiene Management Act | Initial Review | 10 days |
| Post-Supplement Review | 5 days | ||||
| 6 | Domestic/Imported Medicinal Cosmetic License Renewal | 21 days | Cosmetic Hygiene Management Act | Initial Review | 11 days |
| Post-Supplement Review and System Entry | 10 days | ||||
| 7 | Domestic/Imported Medicinal Cosmetic License Transfer |
60 days |
Cosmetic Hygiene Management Act |
Initial Review | 40 days |
| Post-Supplement Review and System Entry | 20 days | ||||
| 8 | Cosmetic Repackaging | 60 days |
Cosmetic Hygiene Management Act |
Initial Review | 40 days |
| Post-Supplement Review | 20 days | ||||
| 9 | Cosmetic Special Import | 60 days |
Cosmetic Hygiene Management Act | Initial Review | 40 days |
| Post-Supplement Review | 20 days | ||||
| 10 | Cosmetic Registration Written Inquiry | 60 days |
Cosmetic Hygiene Management Act |
Initial Review | 40 days |
| Post-Supplement Review | 20 days | ||||
| 11 | Appeal Case Review (Cosmetics) |
60 days |
Cosmetic Hygiene Management Act |
Review of Original Submission | 20 days |
| Review of Appeal Materials | 40 days |
Cosmetic Manufacturing Site Management and Laboratory Accreditation Category
| No. | Application Item | Processing Period (Days) | Legal Basis | Key Work Stages | Processing Days |
| 1 | Domestic/Imported Cosmetic Manufacturing Site Written Document Review | 200 days | Cosmetic Hygiene and Safety Management Act | Technical Document Review | 90 days |
| Post-Supplement Document Review | 60 days | ||||
| Post-Supplement Re-review | 30 days | ||||
| Final Approval | 20 days | ||||
| 2 | Domestic/Imported Cosmetic Manufacturing Site GMP On-Site Inspection Report Review | 200 days | Cosmetic Hygiene and Safety Management Act | Post-Supplement Re-review | 180 days |
| Final Approval | 20 days | ||||
| 3 | Domestic Cosmetic Manufacturing Site GMP Inspection Application Review | 100 days | Cosmetic Hygiene and Safety Management Act | Document Review | 20 days |
| Post-Supplement Document Review | 30 days | ||||
| Post-Supplement Re-review | 30 days | ||||
| Final Approval | 20 days | ||||
| 4 | Imported Cosmetic Manufacturing Site GMP Inspection Application Review |
200 days |
Cosmetic Hygiene and Safety Management Act |
Document Review | 30 days |
| Schedule Arrangement | 50 days | ||||
| GMP On-Site Inspection | 80 days | ||||
| Final Approval | 40 days | ||||
| 5 | Domestic/Imported Cosmetic Manufacturing Site Amendment Review |
130 days |
Cosmetic Hygiene and Safety Management Act |
Technical Document Review | 60 days |
| Post-Supplement Document Review | 30 days | ||||
| Post-Supplement Re-review | 20 days | ||||
| Final Approval | 20 days | ||||
| 6 | Appeal Case Review—Domestic/Imported Cosmetic Manufacturing Site Documents, GMP Inspection Report, GMP Inspection, and Amendment |
100 days |
Cosmetic Hygiene and Safety Management Act |
Technical Document Review | 90 days |
| Final Approval | 10 days | ||||
| 7 | Cosmetic Manufacturing Site GMP Certificate Application | 30 days | Cosmetic Hygiene and Safety Management Act | Document Review and Request for Supplement | 20 days |
| Final Approval and Seal | 10 days | ||||
| 8 | Cosmetic Manufacturing Site GMP Inspection Related Written Inquiry |
90 days |
Cosmetic Hygiene and Safety Management Act |
Information Collection | 75 days |
| Final Approval | 15 days | ||||
| 9 | Precision Medical Molecular Testing Laboratory Accreditation Written Document Review |
180 days |
Precision Medical Molecular Testing Laboratory Accreditation Management Points |
Administrative Preliminary Review | 30 days |
| Post-Supplement Review | 10 days | ||||
| Technical Document Review | 90 days | ||||
| Post-Supplement Document Review | 30 days | ||||
| Final Approval | 20 days | ||||
| 10 | Precision Medical Molecular Testing Laboratory Accreditation On-Site Inspection Report Review | 200 days | Precision Medical Molecular Testing Laboratory Accreditation Management Points | Post-Supplement Document Review | 180 days |
| Final Approval | 20 days | ||||
| 11 | Appeal Case Review—Precision Medical Molecular Testing Laboratory Accreditation | 100 days | Precision Medical Molecular Testing Laboratory Accreditation Management Points | Technical Document Review | 90 days |
| Final Approval | 10 days | ||||
12 |
Precision Medical Molecular Testing Laboratory Accreditation Related Written Inquiry |
90 days |
Precision Medical Molecular Testing Laboratory Accreditation Management Points |
Information Collection | 75 days |
| Final Approval | 15 days |
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