Taiwan Food and Drug Administration
Taiwan regulator; administers the Pharmaceutical Affairs Act and, as a PIC/S member since 2013, applies the PIC/S GMP standard.
What this page does not claim
SPEQ curates and cross-references these bodies. It is not affiliated with, accredited by, or endorsed by any of them, and a count of decoded standards is a measure of SPEQ’s coverage, not of a body’s importance.
WHAT TFDA COVERS
Taiwan’s Food and Drug Administration (TFDA) regulates medicines, medical devices, food, and cosmetics under the Pharmaceutical Affairs Act. For medicine manufacture it adopts the PIC/S Guide to Good Manufacturing Practice as its national GMP standard, and a site must meet that standard to hold the GMP approval manufacturing requires.
WHAT TFDA PUBLISHES
- 01Regulations and requirements under the Pharmaceutical Affairs Act
- 02The adopted PIC/S GMP standard and related manufacturing requirements
- 03GMP approval and inspection information
- 04Drug approval, recall, and safety information
- 05An English-language portal summarising key requirements
HOW ITS REQUIREMENTS BITE
TFDA administers manufacturing control and GMP approval through the Pharmaceutical Affairs Act and inspects sites against the adopted PIC/S GMP standard. It announced the move to PIC/S GMP in 2007 with full industry implementation required by 31 December 2014, and Taiwan — participating as “Chinese Taipei” — became a PIC/S participating authority on 1 January 2013, which supports mutual reliance on inspection outcomes with other members.
What practitioners get wrong
- Taiwan adopted the PIC/S GMP Guide wholesale rather than maintaining a divergent code — work from the current PE 009 text.
- Taiwan participates in PIC/S as “Chinese Taipei”; the membership is what supports reliance on inspection outcomes.
- Primary texts are largely in Chinese; TFDA maintains an English portal, but confirm requirements against the governing Chinese instrument.
- GMP approval is a legal condition of manufacturing under the Pharmaceutical Affairs Act, not a voluntary benchmark.
What an inspection under this authority actually probes
WHERE IT SITS INTERNATIONALLY
By adopting the PIC/S GMP Guide and joining PIC/S in 2013, Taiwan aligned its manufacturing standard with the PIC/S membership and, through it, with EU GMP. The alignment is deliberate convergence, while the binding obligation remains Taiwanese law administered by TFDA.
TFDA STANDARDS SPEQ DECODES · 1
DISCIPLINES IN TFDA’S REMIT
TFDA: frequently asked questions
Reference answers on Taiwan Food and Drug Administration’s mandate, what it publishes, and how its requirements acquire force.
When did Taiwan join PIC/S?
Taiwan, participating as “Chinese Taipei”, became a PIC/S participating authority on 1 January 2013. TFDA had announced adoption of the PIC/S GMP standard in 2007, with full industry implementation required by 31 December 2014.
What law underpins Taiwan’s GMP?
The Pharmaceutical Affairs Act. The adopted PIC/S GMP standard acquires force through that domestic framework, so GMP approval is a legal condition of manufacturing.
Does Taiwan use its own GMP code?
No. TFDA adopted the PIC/S GMP Guide, which is kept harmonised with EU GMP, rather than maintaining a separate national code.