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Generic Drug Registration Requirements in Taiwan

  • Taiwan’s pharmaceutical market was estimated $2.9 Billion in 2021 growing at the rate of 3% CAGR

  • Taiwan’s market is dependent on imported drugs

  • Taiwan is part of Asia market strategy for many generic pharmaceutical and biotech companies along with China and Hong Kong

  • Considering regional regulations and language requirements, it is imperative for foreign manufacturers to work with a regional regulatory partner for drug registration in Taiwan

Drug Registration Taiwan FDA
Drug Registration in Taiwan

Regulatory Bodies in Taiwan for Drug Registration

Pharmaceutical products are regulated by Taiwan Food and Drug Administration in Taiwan under the Ministry of Health. The key objectives of Taiwan FDA are –

  • To establish an internationalized regulatory system for food, dugs, medical devices and cosmetics.

  • To establish integrated risk management scheme and mechanism.

  • To enable information disclosure and transparency.

  • To simplify the review process, and facilitate development of biotechnology and pharmaceutical industries.

  • To promote international cooperation and information exchange.

Classification of Generic Drugs in Taiwan

Generic drugs are classified in two categories as per Taiwan FDA

1- The active ingredient in the generic drug is on the list of post marketing surveillance

2- The active ingredient in the generic drug is not on the list of post marketing surveillance

Registration Process of Generic Drugs in Taiwan

Foreign manufacturers need to submit the complete application for ANDA as per document requirements to Taiwan FDA. In parallel a GMP application also need to be submitted following PIC/s GMP requirements.

The ANDA application will then be reviewed by TFDA/CDE Review team including both Administrative and Technical Documents. Based on the Assessment Report from the Review team, the Advisory Committee (AC) will take the final decision in TFDA.

The application for drug need to be submitted by subsidiary of the Company, local agent or a Contract Research Organization (CRO)

Companies can request a pre-ANDA meeting with TFDA to discuss the content and format of the application

Documents Required for Drug Registration in Taiwan

In Taiwan, the FDA requires a Reference Drug to file for Abbreviated New Drug Application (ANDA). In addition, data from Bioequivalence studies need to be submitted (BE studies). GMP data along with labelling needs to be part of the application.

Registration Fee for Generic Drugs in Taiwan

  • The active ingredient in the generic drug is on the list of post marketing surveillance TWD 80,000

  • The active ingredient in the generic drug is not on the list of post marketing surveillance TWD 50,000

Bioequivalence Studies Report Requirement in Taiwan

TFDA requires generic drugs with active ingredients under pharmacovigilance and those whose pharmacovigilance period has expired need to submit the bioequivalence study reports when applying for registration.

BE Waiver in Taiwan

The bioequivalence study can be waived if the drug product meets certain criteria in Taiwan

  1. Intravenous administered injection product

  2. Drug products inhaled as gas or vapors

  3. Generic drugs with topical uses that are not subcutaneously or intradermally absorbed

  4. Ophthalmic and otic generic drugs

  5. Oral administered generic drugs with excipients that do not affect absorption of the active ingredient

  6. Extravascular administered injection product where the injectable solution of generic drug that have same pH value as compendia or brand products. Except for the preservatives and buffers, its formulation should be same as the brand drugs

Application for Import Certificate

The application for Import Certificate in Taiwan requires following information:

- Applicant Details

- Country of Origin

- Country of Seller

- Shipping Port

The TFDA will issue the Import Certificate including the Issue and Expiration Date

Artixio provides regulatory services using its team of experienced regulatory consultants based in Taiwan. We support generic drugs, OTC products, new drugs registration and life cycle maintenance.


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