Taiwan · Taiwan Food and Drug Administration · Over-the-counter
Review target
180 days
performance goal
Legal time limit
-
Not published
Steps
5
7 requirements
Application fee
-
Taiwan's main non-prescription class is the indicated drug, recommended by a doctor, pharmacist or assistant pharmacist. Products whose ingredients and strengths are listed in the review standard are registered against that standard. Non-prescription products for mild symptoms whose ingredients and strengths are covered by the standard.
The official review target is 180 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Submit the application; 2. Administrative and technical review; 3. Applicant supplies missing data (clock stopped); 4. Decision; 5. Collect the drug license.
Outcome: Drug license in the indicated drug category, valid for 5 years. Valid for 5 years.
Legal basis: Pharmaceutical Affairs Act Article 8; review standard for indicated drugs (2019-08-05)
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).
About 91 days end to end with the official step targets, of which up to 61 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal. Official processing period in calendar days, as announced by the TFDA. It is a target, not an actual review time. | 180 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Taiwan: Proprietary medicine registration (class A and class B). 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 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.