TFDA Simplifies Drug Clinical Trial Application Requirements Effective July 2026

On June 1, 2026, Taiwan's Food and Drug Administration (TFDA) issued Official Letter FDA Drug No. 1151405064 announcing simplified documentation requirements for drug clinical trial protocol applications, including both new submissions and protocol amendments. The revised requirements will take effect on July 1, 2026.

While the revisions are primarily procedural, they provide a clear indication of the TFDA's evolving risk-based regulatory approach to clinical trial oversight. The agency is removing requirements that provide limited additional review value while maintaining controls in areas that continue to present operational, quality, or participant protection considerations.

For sponsors conducting clinical development programs in Taiwan, the revisions should reduce avoidable administrative burdens while providing greater clarity around decentralized clinical trial expectations.

TFDA Targets Administrative Burden Without Relaxing Oversight

The TFDA's latest revisions focus on two areas that frequently create documentation challenges for sponsors:

• Comparator and concomitant medications
• Decentralized clinical trial measures

Although the agency is reducing documentation requirements, the changes do not reduce regulatory oversight. Instead, they reflect a more proportionate, risk-based approach to determining which information is necessary for regulatory review.

Comparator Drug Documentation Gets a Risk-Based Reset

Under the existing "Guideline for Technical Documents of Drug Clinical Trial Protocols," sponsors using comparator drugs or concomitant medications approved in one of the world's ten advanced pharmaceutical markets have been required to submit:

• Proof of marketing authorization 
• Manufacturing site name and address 
• Product composition 
• Certificate of Analysis (CoA) 

Effective July 1, 2026, sponsors will no longer be required to submit a Certificate of Analysis for these products.

 Following a risk assessment and practical review, the TFDA concluded that Certificates of Analysis for products already approved in highly regulated jurisdictions no longer need to be routinely submitted. Importantly, the agency continues to require evidence of regulatory approval and core product information.

The TFDA will also permit applicants to provide Marketing Authorization Holder (MAH) information when details of the actual manufacturing site are unavailable.

TFDA Refines Decentralized Clinical Trial Documentation Requirements

The second major change concerns decentralized clinical trial (DCT) measures implemented in Taiwan.

Before the revision, sponsors generally described proposed decentralized measures in the application cover letter and submitted the "Drug Clinical Trial Decentralised Measures Checklist."

According to the TFDA, certain decentralized trial activities have become routine practice in Taiwan. As a result, requiring checklist submission in every case is no longer considered necessary.

Sponsors must continue to follow the "Guideline for the Implementation of Decentralised Measures in Drug Clinical Trials," but applications involving routine decentralized measures may no longer require the additional checklist documentation.

Higher-Risk Decentralized Activities Remain Subject to Additional Review

The TFDA has identified specific decentralized clinical trial activities for which sponsors must continue to describe the proposed measures in the application letter and submit the Drug Clinical Trial Decentralised Measures Checklist.

Supply of Investigational Products Outside the Original Trial Site

Checklist submission remains mandatory when investigational products will be supplied outside the original clinical trial institution. This requirement reflects the additional operational, traceability, product accountability, and oversight considerations associated with supplying investigational medicinal products outside the original clinical trial institutions.

Home Visits

Sponsors proposing home visit activities must continue to submit the checklist. Home-based trial procedures introduce additional considerations relating to participant safety, investigator oversight, protocol compliance, and data integrity, justifying continued regulatory review.

Other Advanced Decentralized Measures

The checklist also remains required for activities falling under Item 2 and Item 3 of the TFDA's decentralized measures framework. These categories generally involve more complex decentralized approaches that may require enhanced regulatory oversight.

Key Considerations for Sponsors

Sponsors preparing new clinical trial applications or protocol amendments effective from July 1, 2026, should consider:

• Updating internal submission templates and checklists 
• Reviewing comparator and concomitant drug documentation requirements 
• Assessing whether proposed decentralized measures fall within categories that still require checklist submission 
• Reviewing the updated TFDA Drug Clinical Trials (including BA/BE Studies) FAQ before submission
• Confirming that local regulatory teams and service providers are aligned with the revised requirements 

Companies managing multinational clinical development programs should also evaluate whether Taiwan-specific submission procedures and standard operating procedures require updates to reflect the new framework.

Final Thoughts

The TFDA's latest revisions represent a targeted effort to streamline drug clinical trial application processes without reducing regulatory oversight. By removing selected documentation requirements for comparator and concomitant medications and limiting mandatory submissions for routine decentralized clinical trial activities, the TFDA is signaling a more mature,proportionate, and risk-based approach to clinical trial regulation.

For international sponsors, the changes may improve submission efficiency and reduce documentation challenges, particularly in global studies involving multiple products, suppliers, and decentralized operational models. As Taiwan continues to refine its clinical trial regulatory framework, sponsors shouldensure that submission strategies, operational procedures, and quality systems remain aligned with evolving TFDA expectations.

Cisema supports companies navigating clinical trial requirements across Asia through expert pharmaceutical consulting services tailored to local regulatory frameworks.

To assess how the TFDA's July 2026 changes may affect your submission strategy, decentralized trial plans, and regulatory compliance requirements in Taiwan, contact Cisema today.

Further Information

• Explore Cisema’s Pharmaceutical consulting services across the Asia-Pacific region.

References

• TFDA Simplifies Documentation Requirements for Drug Clinical Trial Applications (Including New Applications and Amendments)