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 a strong emphasis on biotech and R&D, the Taiwanese pharma sector has evolved into a dynamic and high-potential market. The country’s pharmaceutical and biomedical industries form an important part of its advanced-economy mix, supported by a growing network of local and international manufacturers specializing in APIs, biologics, injectables, and contract manufacturing services.

Investors and global manufacturers seeking stable, quality-driven market access across Asia find Taiwan increasingly attractive, thanks to Regulatory predictability, compliance rigor, and opportunities for strategic partnerships.

Medicinal Product Classification in Taiwan

Taiwan classifies medicinal products under the Pharmaceutical Affairs Act (PAA) and TFDA regulations into the following categories:

1. Prescription Drugs

Medicines requiring a licensed physician’s prescription due to risk profile, interactions, or need for medical supervision. Includes chemical drugs, biologics, oncology products, and specialty therapies.

2. Over-the-Counter (OTC) Drugs

Products considered safe for self-medication when used as per labeled instructions, typically treating common or minor conditions.

3. Controlled Drugs

Subject to strict oversight by the Taiwan Food and Drug Administration – Controlled Drugs Division due to risks of dependence or abuse.

Controlled categories include:

• Schedule I: High dependence risk (e.g., narcotics)
• Schedule II: Medicines with abuse potential but recognized medical use
• Schedule III–IV: Lower risk-controlled substances

All controlled drugs follow the Controlled Drugs Act for import, distribution, storage, prescribing, and record-keeping.

4. Traditional Chinese Medicine (TCM)

Herbal formulas, granules, and traditional medicinal preparations are regulated under the TCM Act, with quality standards defined in the Taiwanese Herbal Pharmacopeia.

5. Biologics & Advanced Therapies

Includes vaccines, plasma derivatives, biosimilars, cell/gene therapies—regulated under TFDA’s Medicinal Products Division & Biologics Division with stricter dossier and GMP requirements.

Medicinal Product Drug Registration & Approval (TFDA)

The Taiwan Food and Drug Administration (TFDA) oversees registration, licensing, GMP compliance, import, and post-marketing surveillance of medicinal products.

Registration Process Overview

1. Determine Product Classification

Classification as a chemical drug, OTC, biologic, biosimilar, new drug, generic, TCM, or controlled substance determines dossier format and review pathway.

2. Appoint a Local Taiwan License Holder (TLH)

Foreign manufacturers must authorize a Taiwan-based local agent/MAH to submit dossiers, manage communication with TFDA, and handle product lifecycle and PV obligations.

3. Prepare & Submit the Dossier

Dossiers must follow ICH CTD format and include:

• Administrative documents (CPP, GMP, LOA, certificates)
• Quality/CMC data aligned with ICH Q8–Q12
• Non-clinical and clinical evidence
• Stability data as per TFDA climatic zone requirements
• Labeling, packaging, and risk-management documents (RMP/PMS)

Submissions are made via the TFDA online application portal.

4. Scientific Review & Queries

TFDA reviews quality, safety, and efficacy.
Expert committees may raise queries; responses must be submitted within specified timelines.

5. Approval & License Issuance

Once approved, TFDA issues a Drug License (valid for 5 years).

• New drugs, biologics, and priority products may have conditional validity (3–5 years) under special evaluation.

6. Renewal & Variations

Renewal is required every 5 years with updated compliance documents.
Variations categorized as:

• Major changes: prior approval needed
• Minor changes: may follow notification-only pathway

7. Pharmacovigilance & Lifecycle Compliance

MAHs must:

• Maintain a PV system
• Submit periodic safety update reports
• Report serious adverse drug reactions
• Support recalls and market surveillance