How medicines and medical devices get approved in Taiwan

A full application for a drug with a new active ingredient. The TFDA reviews quality, nonclinical and clinical data and may ask for a bridging study evaluation. The license is valid for 5 years.

Full application, new active substance · target 360 days · verified October 3, 2026

Application for a product that uses known ingredients in a new therapeutic combination, a new route, a new dosage form, a new dose or a new strength. These products follow the new drug rules.

Full or mixed application, known active substance · target 300 days · verified October 3, 2026

A change application that adds or changes an indication or a dosage on an existing drug license. The holder submits full clinical reports or literature.

Full or mixed application, known active substance · target 180 days · verified October 3, 2026

New drugs that meet two of three criteria (new drug, serious disease with unmet medical need, government-supported development) can be reviewed in 240 days instead of 360. The TFDA decides on the designation within 30 days.

Priority or accelerated review · target 240 days · verified October 3, 2026

New drugs for serious diseases with unmet medical needs can be approved on a surrogate endpoint that is reasonably likely to predict clinical benefit. They get the 240 day priority review and must confirm the benefit after approval.

Conditional or accelerated approval · target 240 days · verified October 3, 2026

New active substances already approved in the United States, the European Union or Japan can get a shorter review. Type 1 (two of the three approvals) has a 180 day review. Type 2 (all three approvals with the same CMC data) has a 120 day review.

Reliance route, abridged review · target 180 days · relies on EU, JP, US · verified October 3, 2026

Drugs for serious or rare diseases with early clinical evidence of substantial improvement, and a meaningful trial in Taiwan, can get two-way consultation, module-based rolling review of the CTD dossier, and the 240 day priority review.

Intensive development support designation · target 240 days · verified October 3, 2026

New drugs for serious diseases that mainly affect children or are rare (prevalence of 5 in 10,000 or less) can be designated. They get the 240 day priority review, relaxed document rules and, for some pediatric products, a priority review voucher.

Orphan or rare disease designation · target 240 days · verified October 3, 2026

The TFDA can allow the manufacture or import of a specific unlicensed drug for life-threatening or severely disabling diseases when there is no suitable alternative in Taiwan, or for public health emergencies.

Early or compassionate access · verified October 3, 2026

Registration route for biological products, including recombinant proteins, vaccines, human plasma products and allergens. The TFDA reviews detailed manufacturing and control data. Vaccines and other listed biologics also need batch lot release before sale.

Full application, new active substance · target 360 days · verified October 3, 2026

Registration of a biological product that is highly similar to a reference biologic approved in Taiwan, with no clinically meaningful differences. The application rests on a stepwise comparability exercise.

Biosimilar application · verified October 3, 2026

Registration of a product with the same ingredient, dosage form, strength and indication as a drug already approved in Taiwan. The usual evidence is a bioequivalence study, plus a patent linkage declaration.

Generic application · target 210 days · verified October 3, 2026

Taiwan's main non-prescription class is the indicated drug, recommended by a doctor, pharmacist or assistant pharmacist. Products whose ingredients and strengths are listed in the review standard are registered against that standard.

Non-prescription monograph · target 180 days · verified October 3, 2026

Proprietary medicines are the lowest-risk drug class. They are used without a doctor's instruction and are reviewed against fixed standard tables. Class B products can also be sold outside pharmacies.

Non-prescription monograph · verified October 3, 2026

Serums, antitoxins, vaccines, toxoids and bacterial suspensions cannot be sold until the regulator has sampled and tested each batch and applied a release seal. This step follows product registration.

Other route · target 70 days · verified October 3, 2026

Since 1 January 2026, gene therapy, cell therapy, tissue engineered and composite products are regulated as regenerative medicinal products. A full license is valid for 5 years. Composite products combine device-type structural materials with cells or genes.

Full application, new active substance · verified October 3, 2026

A time-limited permit for cell, gene or tissue products that treat life-threatening or severely disabling diseases, granted after Phase II when safety and preliminary efficacy are shown. It lasts up to 5 years, cannot be renewed and requires an efficacy confirmation trial.

Conditional or accelerated approval · target 120 days · verified October 3, 2026

Low-risk Class 1 items that the regulator has announced are placed on the market by online listing instead of a license. The listing must be confirmed every October or it lapses.

Device: premarket notification · verified October 3, 2026

Class 1 devices that are not on the listing list need a license from the TFDA. The application is short: firm license, quality system proof as needed, product description and test data where specified.

Device: registration or licence with the regulator · target 80 days · verified October 3, 2026

Medium-risk Class 2 devices need a TFDA license. Applicants file preclinical test data and, where needed, clinical evidence. Some evidence can be replaced by approvals from partner regulators.

Device: registration or licence with the regulator · target 140 days · relies on EU, US · verified October 3, 2026

High-risk Class 3 devices need a TFDA license with full preclinical and clinical evidence. Drug-containing devices that work mainly as devices are placed in Class 3.

Device: premarket approval by the regulator · target 200 days · verified October 3, 2026

Devices, including IVDs, with no similar product licensed or listed in Taiwan follow a longer review that includes the device advisory committee. The fee covers new principles, structures, materials or performance claims.

Device: new low or moderate risk device · target 220 days · verified October 3, 2026

Devices that are first in the world, with no similar product anywhere, are reviewed with a foreign maker site inspection and a clinical trial in Taiwan instead of a certificate of free sale.

Device: new low or moderate risk device · target 365 days · verified October 3, 2026

A device license application can be reviewed with priority when the device addresses a life-threatening or severely disabling disease without alternatives, a rare disease, or an urgent need, including government-supported products tested in Taiwan.

Priority or accelerated review · verified October 3, 2026

For devices with clear benefit and no major risk that meet an unmet or urgent need, or that are innovative, the TFDA can grant a license with a shorter validity linked to a safety surveillance or post-market study plan.

Conditional or accelerated approval · verified October 3, 2026

The TFDA can approve the manufacture or import of specific unlicensed devices for serious diseases without alternatives, emergencies, trials, samples, personal use and some other listed cases.

Early or compassionate access · verified October 3, 2026

In vitro diagnostic reagents, instruments and software are medical devices in Taiwan. Class 2 and Class 3 IVDs need a TFDA license under the same rules as other devices, with their own processing periods.

Device: registration or licence with the regulator · target 150 days · verified October 3, 2026