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New Drugs, Generics, Biosimilar Regulations in Taiwan

In Taiwan, the regulatory authority responsible for ensuring the safety and efficacy of various products (new drugs, generics, biosimilars regulations) is the Taiwan Food and Drug Administration (TFDA). It falls under the Ministry of Health and Welfare (MOHW)

Here's a quick rundown of Taiwan's Regulatory Affairs landscape:

  • Main Authority: Taiwan Food and Drug Administration (TFDA)

  • Overseen by: Ministry of Health and Welfare (MOHW)

  • Products Regulated: Drugs, medical devices, cosmetics, food, and certain biological products like cellular therapies.


New Drugs, Generics, Biosimilar Regulations in Taiwan FDA


Key Points to Consider Regarding New Drugs, Generics, Biosimilar Regulations in Taiwan:

  • Registration Process: Taiwan has a tiered registration system based on product risk classification. Higher-risk products require more stringent documentation and testing. This process involves submitting detailed documentation, including data on product safety, efficacy, quality, and manufacturing processes


New Drugs, Generics, Biosimilar Regulations in Taiwan


List of required Documents

  1. Application Form

  2. Refuse to File Checklist

  3. GMP Certificate and PMF

  4. Label- Chinese, English and Origin

  5. Certificate of Pharmaceutical product- Reference Countries

  6. Risk Management Plan

  7. Bridging Study Evaluation

  8. Module-2, 3, 4 & 5 as per ICH CTD

New Drugs, Generics, Biosimilar Regulations in Taiwan
  • Good Manufacturing Practices (GMP): Manufacturers must adhere to GMP standards set by the TFDA to ensure the quality and consistency of pharmaceutical products. Regular inspections may be conducted to assess compliance with GMP requirements. The Documents required are GMP certificate, Inspection report and CAPA, Quality Agreement, Site Master File

  • Clinical Trials: Companies conducting clinical trials in Taiwan must adhere to regulatory requirements set by the TFDA. This includes obtaining approval for trial protocols, ensuring participant safety, and complying with ethical standards.

  • Foreign Manufacturers: The TFDA conducts on-site inspections for local manufacturers, while foreign manufacturers need to submit Quality System Documentation (QSD)

  • Post-Market Surveillance and Pharmacovigilance: Continuous monitoring of drug safety and efficacy through post-market surveillance activities, including adverse event reporting, product recalls, and risk assessment.

  • Pricing and Reimbursement: The Taiwan government employs various mechanisms to ensure affordable access to essential drugs, the newly proposed DET drug price methodology impacts the pricing of the drugs in Taiwan

  • Timelines and Agency Fees: The timeline for New Drug and Biosimilar submissions is approximately 12 months-15 months whereas for New Generics it is 10 months-13 months based on the type of application submitted. The TFDA fees varies for New Drug and Biosimilars, it is USD 50000, whereas for New Generic, it is USD 2700-4700. The paper review (PMF) fees is approx. USD 10,000

  • Evolving Regulations: The regulatory landscape in Taiwan can be dynamic, so staying updated on the latest requirements is crucial.

Navigating pharmaceutical regulatory affairs in Taiwan requires a thorough understanding of local laws and regulations, as well as effective communication and collaboration with regulatory authorities. Compliance with regulatory requirements is essential to ensure the safety, efficacy, and quality of pharmaceutical products while facilitating their availability to patients in Taiwan.



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