TFDA Updates Processing Time Limits for Public Applications in Taiwan

On August 17, 2026, the Taiwan Food and Drug Administration (TFDA) revised and renamed its application processing time limits table as the ‘TFDA Processing Time Limits Table for Public Applications’ (人民申請案件處理期限表), effective immediately.

The revision was issued under Article 51(1) of Taiwan’s Administrative Procedure Act, which requires administrative authorities to publish processing periods for public applications. The updated table took effect immediately and adds eight new application items while amending two existing items.

At a Glance

• Broad Regulatory Coverage:  The TFDA table covers application types across pharmaceuticals, medical devices, IVDs, cosmetics, health foods, manufacturing compliance, and other related sectors.
• 8 New Application Items: The revised table adds eight application items and amends two existing items, including defined processing periods for certain emerging application types. 
• Calendar days, not business days: Published processing periods are stated in calendar days, periods for applicants to provide supplementary information are not counted toward TFDA’s processing time. 
• Effective Immediately: The revised table took effect on August 17, 2026, requiring companies to use the updated application items and processing periods for current regulatory planning.

How the Updated TFDA Application Processing Times Work

 For application items with stage-level allocations, the published processing period may be divided into sequential review stages:

• Stage 1: Intake & Administrative Screening: Initial document classification and intake review determine file completeness (typically 5–30 days).
• Stage 2: Technical Evaluation & Queries: Depending on the application type, this stage may include technical or document review, expert consultation, laboratory evaluation, and request for supplementary information.
• Stage 3: Final Decision & Administrative Closure: Where applicable, the final stage covers the administrative decision, certificate generation, or license issuance. 

Important Note: Timelines reflect active government review time only and pause during applicant response windows.

Updated TFDA Processing Times by Product Category

 The TFDA table covers a wide range of application types, with processing periods varying according to the type and complexity of the application. Below is an overview of key published processing periods across major product areas.

Pharmaceuticals & Biologics

For pharmaceuticals and biologics, TFDA processing times vary according to the complexity of the application and the clinical evidence required.

New Drug Applications (NDAs):

• NDA with safety and efficacy clinical data: 300 days
• NDA involving novel active ingredients or biologics: 360 days
• Breakthrough drug for rare diseases: 360 days
• NDA without clinical data: 200 days

Established Products:

• Generic drug registration: 210 days
• OTC-compliant drug filing: 180 days

API Drug Master Files (DMFs):

• New applications: 180 days
• Drug-linked filings: 90 days
• Renewals: 60–180 days, depending on complexity

Clinical and Post-Approval Applications:

• MRCT protocol review: 15 days
• Standard IND: 45 days
• Complex biotech IND: 120 days
• RMP approval: 90–120 days
• Permit transfer, renewal, or cancellation: 30–60 days

Medical Devices & In-Vitro Diagnostics (IVDs)

Processing times are primarily driven by product risk classification and predicate availability.

Product Registration:

• Class I medical devices: 80 days
• Class II general medical devices: 140 days
• Class III medical devices: 200 days
• Class II IVD diagnostic reagents: 150 days
• Class III IVD diagnostic reagents: 200 days

Novel and Non-Predicate Devices:

A first-in-world medical device without an existing predicate may require up to 365 days, including up to 245 days for advisory board review and overseas site inspections.

• Domestic or imported non-predicate devices using equivalent technology (including IVDs): 220 days

Quality and Manufacturing Procedures:

• Foreign factory QSD review — standard/subsequent filing: 120 days
• Initial or complex QSD audit: 180 days
• Overseas on-site plant audit: 240 days
• Medical device GDP compliance review: 180 days

Planning implication: These quality and facility procedures should be incorporated into the overall registration timeline rather than treated as separate administrative steps.

Cosmetics & Emerging Technologies

 The revised table provides defined processing periods for certain cosmetics-related applications, including human cell-derived exosomes for cosmetic use.

Human Cell-derived Exosome Applications:

• Case review: 200 days
• Change application: 120 days
• Replacement or re-issuance: 30 days

Other Cosmetic Procedures:

• Safety evaluation involving animal testing: 90 days
• Amendments: 45 days
• General cosmetic property inquiries: 60 days
• Special import permits: 60 days

Health Foods, Supplements & Food Safety

Health food and food safety applications can involve substantially longer processing periods.

Track 1 Individual Health Food Evaluation — 340 days:

• Administrative intake: 60 days
• Committee review: 96 days
• Laboratory testing: 60 days
• Final administrative closure: 24 days

Other Health Food Pathways:

• Track 1 re-evaluation: 180–260 days
• Track 2 standardized-criteria application: 120 days

GMO Applications:

• Initial registration — first review: 540 days
• Initial registration — second review: up to 720 days

By comparison, border import procedures are considerably faster:

• Document-only review: 1 day
• Physical inspection: 2 days
• Sample testing: 9 days

GMP, GTP, and Laboratory Accreditation

 The TFDA table also includes processing periods for manufacturing compliance, tissue practices, and laboratory testing activities:

• Good Manufacturing Practice (GMP): Processing periods for certain overseas Plant Master File (PMF) reviews, imported API GMP applications, and foreign/local cosmetic GMP applications are up to   200 days.
• Good Tissue Practice (GTP): Published processing periods are 180 days for initial applications, 200 days for renewals, and 60 days for modifications.
• Laboratory Testing: Published processing periods range from 25–70 days for certain biologic batch-release testing, while certain chemical analyses involving unknown compounds or method validation have a processing period of 270 days.

Key Actions

 Regulatory teams should consider the following actions when planning current and upcoming Taiwan submissions:

• Review Active and Planned Filings: Cross-reference current and upcoming submissions against the revised table and confirm the applicable application item and processing period.
• Update Planning Timelines: Incorporate the published processing periods into regulatory planning while allowing for applicant response periods and other factors outside TFDA’s processing time.
• Plan Quality Requirements Early: Where applicable, consider QSD, GMP, or other manufacturing requirements early in the submission planning process.
• Prepare for Supplementary Information Requests: Establish an efficient process for responding to TFDA requests to minimize avoidable delays.

Final Thoughts

The revised TFDA table provides companies with updated administrative benchmarks for planning regulatory submissions in Taiwan, including defined processing periods for newly added and amended application items.

These published processing periods should not, however, be treated as guaranteed time-to-market timelines. Applicant response periods, dossier completeness, additional review requirements, and other regulatory activities may affect the overall submission and approval timeline.

Cisema supports international companies in navigating Taiwan’s regulatory requirements, including submission planning, dossier preparation, quality-related filings, and communication with TFDA.

To assess how the updated processing periods may affect your product pipeline and Taiwan market access strategy, contact Cisema today.

Further Information

• Explore Cisema's services for cosmetics registration in Taiwan.
• Learn more about Cisema's medical device registration services in Taiwan.
• Discover Cisema's Pharmaceutical consulting services.

References

• TFDA announcement on the revised processing time limits table (Chinese)
• TFDA Processing Time Limits Table for Public Applications (Chinese)
• Article 51 of Taiwan’s Administrative Procedure Act (Chinese)

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