Taiwan Regulatory News

On April 11, 2024, Taiwan’s Food and Drug Administration under the Ministry of Health and Welfare announced the types of cosmetics and implementation dates for which product information files (PIFs) should be established.

About the Cosmetic PIF

The cosmetic PIF must contain the following (according to Article 3 of the Cosmetic Product Information File Management Regulations):

1. Basic information about the product: the name of the product, the category of the product,
2. dosage form, purpose, the names and addresses of manufacturing facilities, information
3. of product manufacturers or importers.
4. Evidentiary documents of completing product notification.
5. Full ingredient names and the individual content.
6. The outer packaging of the products, containers, labels, or leaflets.
7. GMP compliance certificates or self-declarations which the manufacturing facilities
8. comply with cosmetic Good Manufacturing Practice Regulations.
9. Manufacturing methods and procedures.
10. Usage methods, body parts, dosage, frequencies, and the targeted population.
11. Adverse effects of the product application.
12. Physical and chemical characteristics of the products and individual ingredients.
13. Toxicological data of the ingredients.
14. The product stability test reports.
15. The microbiological test reports.
16. The antimicrobial effectiveness test reports.
17. Supporting information on the functional assessments.
18. Information about the packaging materials which have contact with the products.
19. Product safety information

The Cosmetic Hygiene and Safety Act requires companies to establish a PIF before launching a product in Taiwan, according to the Cosmetic Hygiene and Safety Act.