Taiwan · Taiwan Food and Drug Administration · Over-the-counter
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
4 requirements
Application fee
-
Proprietary medicines are the lowest-risk drug class. They are used without a doctor's instruction and are reviewed against fixed standard tables. Class B products can also be sold outside pharmacies. Simple, mild products that fit the class A or class B standard tables.
1. Manufacturer submits the registration; 2. Review against the proprietary medicine standard; 3. Decision.
Outcome: Drug license for a class A or class B proprietary medicine.
Legal basis: Pharmaceutical Affairs Act Articles 8 and 9; Regulations for proprietary medicines and traditional formula preparations
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Taiwan: Indicated (pharmacist-recommended) drug registration under the review standard. See all routes on the Taiwan page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (6 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.