Taiwan Introduces Risk Assessment and Control Plan Requirements for Semaglutide and Tirzepatide

On July 23, 2026, the Taiwan Food and Drug Administration (TFDA) announced the “Risk Assessment and Control Plan for Drugs Containing Semaglutide and Tirzepatide.” The measure is intended to ensure that these medicines are appropriately prescribed and dispensed, that patients understand potential risks prior to treatment, and that the risk-benefit balance is maintained.

The requirements apply to both existing license holders and applicants subsequently seeking approval for drugs containing semaglutide or tirzepatide in Taiwan.

For existing license holders, the timeline is particularly important: companies have three months from the date of the announcement to prepare and submit their risk assessment and control plans for TFDA review.

Taiwan TFDA Risk Control Plan: Key Deadlines

Existing license holders must prepare and submit their risk assessment and control plan within three months of the July 23 announcement. Once approved, implementation must begin the following day.

For companies seeking to register new semaglutide or tirzepatide products, approval of the plan is required before the drug certificate can be issued. Applicants must therefore:

• Establish a compliant risk assessment and control plan
• Submit the plan to the TFDA for review
• Obtain approval of the plan before receiving the drug certificate
• Begin implementation the day after approval

The framework also introduces ongoing reporting obligations. From the approved execution date, license holders must submit an implementation effectiveness report every 12 months. Each reporting period ends at a defined Data Lock Point (DLP), with the report due within 90 days of the DLP.

Non-compliance will be handled under the relevant provisions of Taiwan’s Pharmaceutical Affairs Act.

What Does Taiwan's Semaglutide and Tirzepatide Risk Assessment and Control Plan Require?

The TFDA framework takes a broad approach to risk management, covering the three groups most directly involved in the safe use of these medicines:

1. Patients
2. Healthcare professionals
3. Relevant personnel within the license holder's organization

The requirements combine patient education, healthcare professional communication, digital information resources, pharmacovigilance and internal staff training.

1. Patient Medication Guide

A Medication Guide must form part of the risk control plan and be written in Chinese using language that is easy to understand.

The guide must emphasize that semaglutide and tirzepatide:

• Require professional medical assessment
• Must be prescribed by a physician
• Must be dispensed by a pharmacist
• Should not be purchased independently, including online or through unknown sources

License holders must work with medical institutions and pharmacies to ensure the Medication Guide reaches patients. It may be provided directly by healthcare personnel during consultation or dispensing, or placed at designated locations within medical institutions for patients to collect, with the medication bag reminding patients to obtain it.

2. Healthcare Professional Risk Communication and Training

The framework places significant emphasis on ensuring physicians and pharmacists receive consistent safety information.

License holders must distribute dedicated letters in Chinese to physicians and pharmacists, with company sales personnel responsible for delivering the communications during routine visits.

They must also provide regular education and training, either in person, online, or in a hybrid format, in collaboration with the relevant physicians' and pharmacists' associations.

Training must:

• Take place at least annually in Taiwan's northern, central, southern, and eastern regions.
• Be conducted separately for physicians and pharmacists.
• Attract at least 100 relevant healthcare professionals per session.
• Provide participants with documentation confirming completion.

Sessions must cover the information provided in the physician and pharmacist letters, together with the potential risks associated with the medicines.

3. Dedicated Product Risk Control Website

The new framework also introduces a significant digital communication requirement.

Each license holder must establish a publicly searchable and interactive section on its company website dedicated exclusively to the product's risk assessment and control plan.

The website must:

• Provide different content pathways for the public and healthcare professionals
• Include an interactive mechanism to assess whether visitors have read or understood the relevant information
• Contain only information relating to the risk assessment and control plan and exclude unrelated drug or disease information
• Make the Medication Guide, physician letter and pharmacist letter available for download

A QR code linking to the dedicated webpage must also be printed on or affixed to the drug packaging.

4. Internal Safety Monitoring and Staff Training

The TFDA's requirements also extend into license holders' internal pharmacovigilance and training processes.

Companies must conduct adverse drug reaction monitoring in accordance with their existing drug safety monitoring plans and:

• Track individual cases.
• Report adverse reactions within legally prescribed timeframes
• Strengthen reporting of use outside approved indications
• Train relevant internal personnel before they undertake related duties
• Maintain records confirming training completion
• Provide ongoing training on the implementation and progress of the plan

Relevant personnel include employees involved in business functions, drug safety monitoring, and customer service.

Training must cover the risk control plan, Medication Guide, physician and pharmacist communications, and adverse reaction monitoring and reporting procedures.

Key Safety Risks for Semaglutide and Tirzepatide

The TFDA’s required patient and healthcare professional communications address a broad range of potential safety concerns:

For NAION, the TFDA materials distinguish between the two active ingredients. For semaglutide, epidemiological data indicate a possible increased risk, while for tirzepatide it remains unclear whether a similar class effect exists. Patients should be advised to seek medical attention in the event of vision loss, rapidly worsening vision, or other visual abnormalities.

The TFDA materials also address reproductive and pregnancy-related risks. For tirzepatide, delayed gastric emptying may affect the absorption and efficacy of oral contraceptives, and potential fetal risks during pregnancy are identified. For semaglutide, patients who become pregnant or are planning pregnancy should be advised to consult their physician regarding potential reproductive risks.

Taiwan TFDA Risk Control Plan: Annual Effectiveness Reporting

The framework requires license holders to assess and report on the effectiveness of their risk control measures.

The annual implementation effectiveness report must assess process indicators, including:

• Delivery of Medication Guides to patients
• Distribution of physician and pharmacist communications
• Healthcare professional training
• Website engagement
• Adverse reaction reporting
• Internal staff training
• Improvements in risk awareness among patients, healthcare professionals and internal personnel

The report must also assess outcome indicators, including whether patients, healthcare professionals and relevant internal personnel have improved their understanding and awareness of the potential risks associated with these medicines.

The report must also cover the results of enhanced monitoring measures, such as drug utilization studies conducted as part of post-authorization safety studies (PASS). Where significant use outside approved indications is identified, license holders must analyze contributing factors, including patient needs, supply channels, system-related factors, and education and communication, and propose appropriate tiered corrective measures.

Finally, license holders must provide five years of domestic sales-volume data, broken down by product and healthcare setting (hospitals, clinics and pharmacies), together with the relevant units of measurement and an estimate of annual exposure per person, including the calculation methodology.

Monitoring Use Outside Approved Indications

Where significant use outside approved indications is identified, companies are expected to analyze contributing factors, including:

• Patient needs
• Supply channels
• System-related factors
• Education and communication

Based on this analysis, license holders must propose appropriate tiered corrective measures to address identified risks and improve the effectiveness of the risk control plan.

Final Thoughts: Preparing for Taiwan’s New Risk Control Requirements

Taiwan's new requirements establish ongoing risk management obligations for companies marketing semaglutide- and tirzepatide-containing products. Compliance extends beyond initial plan submission to implementation, patient and healthcare professional communication, pharmacovigilance, internal training, digital risk communication, and annual effectiveness reporting.

Companies should now assess how the requirements affect their existing compliance framework and, for new products, incorporate them into Taiwan registration planning from the outset.

Cisema supports international pharmaceutical companies with regulatory strategy, pharmacovigilance, and compliance requirements in Taiwan and across the broader Asia-Pacific region, including the assessment and implementation of local risk management requirements.

To explore how these new requirements may affect your current portfolio or upcoming registration plans in Taiwan, connect with Cisema today.

Further Information

• Explore Cisema’s Pharmaceutical consulting services in Asia-Pacific.

References

• Announcement of the "Risk Assessment and Control Plan for Drugs Containing Semaglutide and Tirzepatide"

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