Taiwan GMP Standard
Taiwan’s Food and Drug Administration (TFDA) regulates medicine manufacture under the Pharmaceutical Affairs Act. TFDA adopted the PIC/S Guide to Good Manufacturing Practice as its national GMP standard, with full industry implementation required by 31 December 2014, and Taiwan (as “Chinese Taipei”) became a PIC/S participating authority on 1 January 2013 — the sixth in the Asia-Pacific. Manufacturing sites must meet the PIC/S GMP standard to hold the required GMP approval.
What this does not cover
stated in the document's own scope- Adopts the PIC/S GMP Guide rather than maintaining a divergent national GMP code.
- Sets manufacturing GMP; drug approval and registration are handled separately under the Pharmaceutical Affairs Act.
- Primary regulatory texts are largely in Chinese, with an English-language portal maintained by TFDA.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
Taiwan’s Food and Drug Administration (TFDA) regulates the manufacture of medicines and adopts the PIC/S Guide to Good Manufacturing Practice as its national GMP standard. TFDA announced the move to the PIC/S GMP standard in 2007 and required full industry implementation by 31 December 2014, and Taiwan — participating as “Chinese Taipei” — became a PIC/S participating authority on 1 January 2013. A manufacturing site must meet the adopted PIC/S GMP standard to hold GMP approval, working to the same harmonised text used across the PIC/S membership.
Scope & applicability
Manufacturers supplying the Taiwanese market. TFDA applies the PIC/S GMP standard for manufacturing; drug approval and registration are governed separately under the Pharmaceutical Affairs Act.
Legal basis & how it acquires force
TFDA’s authority rests on the Pharmaceutical Affairs Act, Taiwan’s primary medicines statute, under which manufacturing and GMP requirements are set. The adopted PIC/S GMP standard acquires force through this domestic framework, so GMP approval is a legal condition of manufacturing for the Taiwanese market rather than a voluntary benchmark. TFDA is the competent authority that administers the Act, adopts the GMP standard, and conducts GMP inspections.
Document structure
| Part | Covers |
|---|---|
| Pharmaceutical Affairs Act framework | The statutory basis for manufacturing control and GMP approval in Taiwan |
| Adopted GMP standard (PIC/S Part I) | Basic requirements for medicinal products — quality system, personnel, premises, documentation, production, and quality control |
| Adopted GMP standard (PIC/S Part II) | Basic requirements for active substances used as starting materials |
| Annexes | The PIC/S annexes, including sterile manufacture and qualification and validation |
| GMP approval and inspection | The GMP approval a site must hold and TFDA’s inspection of it |
Key requirements
- Meet the PIC/S GMP standard adopted by TFDA to hold GMP approval.
- Operate a pharmaceutical quality system consistent with the PIC/S GMP Guide.
- Maintain qualification, validation, and documentation to the adopted standard.
Implementation tips
- Taiwan adopted the PIC/S GMP Guide wholesale rather than maintaining a divergent national code — work from the current PE 009 text.
Revision notes
Taiwan (Chinese Taipei) acceded to PIC/S on 1 January 2013; full industry implementation of PIC/S GMP was required by 31 December 2014.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
By adopting the PIC/S GMP Guide, Taiwan aligned its manufacturing standard with the PIC/S membership and, through it, with the EU GMP Guide the PIC/S text mirrors. PIC/S membership from 2013 supports mutual reliance on inspection outcomes among participating authorities. The alignment is deliberate convergence: the international text is applied, while the binding obligation remains Taiwanese law administered by TFDA.
TFDA GMP (PIC/S): frequently asked questions
Quick answers to common questions about TFDA GMP (PIC/S).
When did Taiwan adopt PIC/S GMP?
TFDA announced adoption of the PIC/S GMP standard in 2007 and required full industry implementation by 31 December 2014. Taiwan, as “Chinese Taipei”, became a PIC/S participating authority on 1 January 2013.
What law underpins Taiwan’s GMP?
The Pharmaceutical Affairs Act is the statutory basis; the adopted PIC/S GMP standard acquires force through that domestic framework, so GMP approval is a legal condition of manufacturing.
Is Taiwan’s GMP the same as the international standard?
Effectively, yes. Taiwan adopted the PIC/S GMP Guide, which is kept harmonised with EU GMP, rather than maintaining a separate national code.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.