Announcement regarding the “Risk Assessment and Control Plan for Drugs Containing Semaglutide and Tirzepatide”

Main text

Announcement Regarding the “Risk Assessment and Control Plan for Drugs Containing Semaglutide and Tirzepatide”: This announcement concerns matters related to the “Risk Assessment and Control Plan for Drugs Containing Semaglutide and Tirzepatide.” Basis: Articles 45 and 48 of the Pharmaceutical Affairs Act and Article 10 of the Regulations Governing the Monitoring and Management of Drug Safety.

Announcement: 1. To ensure patients use reconstituted drugs correctly and rationally, and to ensure that all medications are prescribed by a physician after professional evaluation and dispensing by a pharmacist before use, thus maintaining a balance between the risks and benefits of medication; and to ensure patients fully understand the potential risks of reconstituted drugs before use, thereby protecting public medication safety, this department announces the “Risk Assessment and Control Plan for Drugs Containing Semaglutide and Tirzepatide”.

II. All license holders of drugs containing the disclosed ingredients shall, within three months from the date of this announcement, formulate a risk assessment and control plan in accordance with this announcement and submit it to the Food and Drug Administration of the Ministry of Health for review. The plan shall be implemented from the day following the approval. Those who subsequently apply to the Ministry of Health for inspection and registration of drugs containing the disclosed ingredients shall formulate a risk assessment and control plan in accordance with this announcement before obtaining the license and submit it to the Food and Drug Administration of the Ministry of Health for review. The plan shall be implemented from the day following the approval.

3. The implementation effectiveness report of the aforementioned drug risk assessment and control plan shall be submitted to the Food and Drug Administration of the Ministry of Health for review every year (12 months) from the date of approval. Failure to comply with the regulations will be dealt with in accordance with the relevant provisions of the Pharmaceutical Affairs Act.