Taiwan: TFDA requires risk plans for semaglutide and tirzepatide
On 23 July 2026 TFDA announced a risk-evaluation and control plan for products containing semaglutide or tirzepatide, with a three-month deadline for current license holders.
On 23 July 2026 the Taiwan Food and Drug Administration announced a risk-evaluation and control plan for products containing semaglutide or tirzepatide. The stated purpose is that these products are prescribed by a physician and dispensed by a pharmacist, and that patients understand the potential risks before use.
What license holders must do
- Current license holders must prepare a risk-evaluation and control plan within three months of the announcement and submit it to TFDA. The plan is implemented from the day after approval.
- New registration applications for these ingredients must have an approved plan before the license is issued.
- An implementation-effectiveness report is due every 12 months from the approval date. Failure to comply is handled under the Pharmaceutical Affairs Act.
Source: TFDA announcement, 23 July 2026.
Related markets: Taiwan
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