How to Verify a Taiwan Pharmaceutical Manufacturer: GMP, TFDA Records, and Export History

Why Verification Matters

Not all Taiwan pharmaceutical manufacturers are equally positioned for ASEAN export. While Taiwan's pharmaceutical sector operates under TFDA oversight and PIC/S GMP standards, there is meaningful variation in manufacturing capability, export experience, documentation readiness, and regulatory standing.

Conducting proper due diligence before committing to a supply partnership protects importers from registration failures, supply disruptions, and quality incidents.

Step 1: Confirm TFDA Registration Status

The first verification step is confirming that the manufacturer holds current TFDA marketing authorizations for the products of interest.

TFDA maintains an online drug product database where importers can search by product name, active ingredient, or manufacturer to confirm: - The product exists as a TFDA-registered drug - The registration is active (not suspended or expired) - The manufacturer holds the TFDA registration (not a trading company)

Step 2: Verify the GMP Certificate

Request the current GMP certificate directly from the manufacturer. The certificate should be: - Issued by TFDA - Covering the specific manufacturing site and dosage forms relevant to your product - Currently valid (typically 3-year validity) - Clearly identifying the manufacturing site address

Confirm that TFDA is currently listed as a PIC/S member at the PIC/S secretariat website (pic.int).

Step 3: Request a Sample CPP

Ask the manufacturer to provide a sample CPP for the product(s) under consideration. Verify: - Issued by TFDA in WHO Certification Scheme format - Covers the exact product name, strength, and dosage form being evaluated - Currently valid

A manufacturer unwilling or unable to provide a sample CPP — or whose CPP is expired — is a red flag.

Step 4: Assess ACTD Dossier Readiness

Request a list of available ACTD dossier components for the product. A manufacturer with genuine ASEAN export experience should be able to confirm: - A full ACTD Part II (Quality) dossier exists for the product - Zone IVb stability studies have been conducted and at what time points data is available - BE study data is available and from which GCP-accredited facility - Summary of any previous ASEAN market registrations for the product

Step 5: Evaluate Export History and References

Ask for references from existing ASEAN market customers or distributors: - Has the manufacturer supplied this product to Thailand, Malaysia, Singapore, or other ASEAN markets previously? - Are there existing Thai FDA, HSA, or NPRA registered products from this manufacturer? - Can they provide contact references from ASEAN importer partners?

Step 6: On-site or Virtual Facility Audit

For significant supply commitments, consider requesting a facility audit: - In-person visit to the Taiwan manufacturing facility - Virtual audit (video call tour with documentation review) — increasingly accepted - Third-party audit service

Red Flags to Watch For

• →GMP certificate not issued by TFDA (or not from a PIC/S-member authority)
• →Difficulty obtaining CPP or GMP certificate copies promptly
• →ACTD dossier described as "in preparation"
• →No prior ASEAN registration or export experience
• →Resistance to facility audit or reference customer contact
• →Significant price discount suggesting quality cost-cutting

Summary

Importers who conduct structured due diligence — confirming TFDA registration, GMP certificate validity, CPP availability, ACTD dossier readiness, and ASEAN export track record — are significantly better positioned for successful registrations and productive long-term partnerships.