Your TFDA Gateway

However, the regulatory landscape, including the Pharmaceutical Affairs Act, presents specific challenges requiring expert navigation:

The pharmaceutical landscape in Taiwan is a dynamic and evolving sector, regulated by Taiwan's Food and Drug Administration (FDA). The FDA ensures comprehensive oversight to guarantee that:

As the FDA strives to uphold international standards, instilling confidence in both local and foreign brands, understanding the myriad of regulatory guidelines in Taiwan is vital for companies entering the pharmaceutical market.

Successfully navigating these regulatory complexities is crucial for tapping into the potential of Taiwan's pharmaceutical industry. This ensures the safe and effective interplay between imported and local drugs, without compromising on quality. As such, Taiwan presents a compelling opportunity for pharmaceutical companies looking to expand their global footprint.

Do not let Taiwan's regulatory complexities delay your market entry. Our Taiwan-based regulatory experts, with deep TFDA knowledge and Traditional Chinese capabilities, are ready to accelerate your pharmaceutical registration in this compelling $2.9 billion import-reliant market.

to discuss how our Taiwan expertise can unlock opportunities in this dynamic pharmaceutical market with strong government support for foreign investment.

Over 15 years of experience More than 20 new drugs application, including New Chemical Entities (NCE), Biological and combinations Experience in the registration of generic and over-the-counter (OTC) products Experienced in handling a wide range of product types, including New Drug Applications (NDA), vaccines, biologics, biosimilars, radiopharmaceuticals, generics, cosmetics, health supplements, and medical devices.

>14 NDA submissions in Taiwan, including NCE, Generic, and Biological products etc.

Marketing Authorization Holder (MAH) Representation as Regulatory and Local Responsible Person in Pharmacovigilance, liaison with Taiwan Food and Drug Administration, efficiently handling queries and regulatory communications for MAH approval.

Handled Marketing Authorization Transfers, regulatory support for transfer inventory and grace period between Product Owner and Distributor.

Support Plant Master File (PMF) application, obtain Company Good Distribution Practice (GDP) for MAH

Support Tender communications with the Hospital Authority in Taiwan as Marketing Authorization Holder.

Provided comprehensive life cycle management including variations, pharmacovigilance services such as PSUR submission, ICSR, product defect handling, etc.

Delivered regulatory intelligence reports, dossier gap analysis to facilitate successful market entry.

Taiwan’s TFDA and Center for Drug Evaluation run a precise system—from company and pharmaceutical licensing through GDP, PMF/DMF hosting, ExPress submissions, and product licenses. We translate that maze into a sequenced plan for NCEs, new routes, new combinations, new strengths, biologics, vaccines, blood-derived products, and indication supplements.

Foreign manufacturers appoint a local authorized representative to work with TFDA and CDE; CTD dossiers move electronically, and benefit–risk for Taiwanese use sits at the heart of evaluation.

Our team documents assumptions, authority expectations, and decision points so sponsors can approve the plan with clear risk ownership.

Local pharmacists and regulatory specialists stay accountable through query cycles, inspection readiness, and post-approval obligations.

We align labeling, Module 1 localization, and partner communications so commercial launch can follow approval without rework.

Where pathways differ by product class, we sequence filings to protect the critical path and avoid avoidable deficiency letters.

Engagements can scale from a single dossier workstream to a multi-country virtual regulatory function.

Local pharmacists and regulatory specialists stay accountable through query cycles, inspection readiness, and post-approval obligations.