Medicinal Product Support in Taiwan
End-to-End Medicinal Product Regulatory Support in Taiwan

Medicinal Products Regulatory Support in Taiwan – Overview

Taiwan stands at the forefront of biomedical and pharmaceutical innovation in Asia. With a well-established Regulatory framework, globally harmonized GMP standards, and strong biotech investment, Taiwan offers a dynamic environment for medicinal product registration in Taiwan.

The country’s pharmaceutical sector includes local and international manufacturers specializing in APIs, biologics, injectables, and contract manufacturing. Companies seeking reliable Taiwan pharmaceutical market entry benefit from Regulatory transparency and strong oversight by the Taiwan Food and Drug Administration (TFDA).

Freyr supports global manufacturers with Taiwan pharmaceutical Regulatory services, including TFDA dossier submission, Regulatory strategy, and lifecycle management to streamline drug registration in Taiwan.

Medicinal Product Classification in Taiwan

Under the Pharmaceutical Affairs Act (PAA) and Taiwan Food and Drug Administration (TFDA) regulations, medicinal products are classified into several categories relevant to medicinal product registration in Taiwan:

• Prescription Drugs
  Medicines requiring physician supervision due to safety profile or therapeutic complexity.
• Over-the-Counter (OTC) Drugs
  Products are considered safe for self-medication when used according to labelled instructions.
• Controlled Drugs
  Highly regulated medicines overseen by TFDA due to dependence risks.
• Traditional Chinese Medicine (TCM)
  Herbal and traditional medicinal preparations are regulated under Taiwan’s TCM framework.
• Biologics & Advanced Therapies
  Includes vaccines, biosimilars, cell therapies, and gene therapies, subject to stricter TFDA drug approval process and GMP compliance with Taiwan pharmaceutical requirements.

Medicinal Product Drug Registration & Approval (TFDA)

The Taiwan Food and Drug Administration (TFDA) manages drug registration in Taiwan, including licensing, Regulatory review, and post-market monitoring.

Registration Process Overview

1. Determine Product Classification
Products are categorized as chemical drugs, generics, biologics, OTC products, or TCM, which determines the TFDA drug approval process and dossier pathway.

2. Appoint a Taiwan License Holder (TLH)
Foreign manufacturers must appoint a Taiwan License Holder (TLH) responsible for Regulatory submissions and lifecycle management during drug registration in Taiwan.

3. Prepare & Submit the Dossier
A complete TFDA dossier submission must follow the ICH CTD submission Taiwan requirements and include:

• Administrative documents (CPP, GMP certificates, LOA)
• Quality and CMC data
• Non-clinical and clinical evidence
• Stability data for Taiwan climatic conditions
• Labeling and risk management plans

4. Scientific Review & Queries
TFDA evaluates quality, safety, and efficacy and may issue queries during the TFDA drug approval process.

5. Approval & License Issuance
Once approved, TFDA issues a drug license valid for five years, enabling commercial distribution and Taiwan pharmaceutical market entry.

6. Renewal & Variations
Licenses must be renewed every five years, and product changes must follow TFDA variation procedures.

7. Pharmacovigilance & Lifecycle Compliance
Companies must maintain pharmacovigilance requirements in Taiwan, including safety reporting, adverse event monitoring, and Regulatory updates.