[ NATIONAL · TW ]
A food and drug administration operating a PIC/S-aligned inspection programme across medicines and food.
SPEQ synthesis for orientation. It does not determine what applies to a specific product, and an adopted version can move without this page moving with it. Confirm the instrument in force with the authority before relying on it.
ASIA-PACIFIC
The Pharmaceutical Affairs Act, most recently amended on 4 March 2026. Article 57 is the operative provision for manufacture: it requires that a pharmaceutical firm may begin manufacture only after the central competent health authority has completed its inspection, granted approval, and the medicament manufacture licence has been obtained. The same Article requires compliance with the Pharmaceutical Good Manufacturing Practice Regulations, which reach factory facilities, equipment, organization and personnel, production, quality control, storage, logistics, and the handling of customer complaints.
Through a licence granted only after inspection, which inverts the sequence practitioners from some other jurisdictions expect: approval precedes production rather than validating it afterwards. Distribution is governed separately — Article 53-1 establishes licensing for wholesalers and importers and requires compliance with the Western Pharmaceuticals Good Distribution Practice Regulations. The Taiwan Food and Drug Administration has been a PIC/S Participating Authority since January 2013, listed by the Scheme under Chinese Taipei.
WHAT TRANSFERS
Inspection confidence transfers through PIC/S; the licence does not, and neither does the sequencing. Because Article 57 makes prior inspection and approval a precondition of manufacture, a plan that assumes production can begin while an application is processed is not a scheduling risk but a legal one. Note also what the GMP Regulations expressly cover: complaint handling and logistics sit inside the manufacturing standard here rather than in a separate post-market or distribution regime, so an organisation that has partitioned those functions will be assessed across the partition.
Article 57 permits manufacture only once inspection is complete, approval granted, and the medicament manufacture licence obtained. The consequence for project planning is that qualification and licensing sit on the critical path rather than alongside it.
The Pharmaceutical Good Manufacturing Practice Regulations expressly cover handling of customer complaints, alongside production and quality control. Organisations that treat complaints as a pharmacovigilance or commercial function will find them assessed as a manufacturing control.
Article 53-1 licenses wholesalers and importers and points at the Western Pharmaceuticals Good Distribution Practice Regulations. Manufacturing compliance says nothing about distribution compliance; they are separate permissions under separate rules.
Logistics appears in the enumerated scope of the GMP Regulations. Transport and storage arrangements are therefore in scope of the manufacturing standard, not only of the distribution one.
The Pharmaceutical Affairs Act, most recently amended on 4 March 2026. Article 57 requires a medicament manufacture licence, granted only after the central competent health authority has completed inspection and granted approval, and requires compliance with the Pharmaceutical Good Manufacturing Practice Regulations.
No. Article 57 states that manufacture may only begin after inspection has been completed, approval granted and the medicament manufacture licence obtained. That sequencing is a legal requirement, so licensing sits on the critical path for any new manufacturing operation.
The Pharmaceutical Good Manufacturing Practice Regulations reach factory facilities, equipment, organization and personnel, production, quality control, storage, logistics, and the handling of customer complaints. Complaint handling and logistics being named inside the manufacturing standard is the detail most often missed.
Yes. The Taiwan Food and Drug Administration has been a PIC/S Participating Authority since January 2013, listed by the Scheme under Chinese Taipei. Distribution is separately licensed under Article 53-1 with its own Good Distribution Practice Regulations.
ADOPTED, AT A PINNED VERSION
SPEQ has not decoded a pinned adoption edge here yet. That is a gap in this catalog, not a finding about Taiwan: requirements still arrive through the authorities below, and the edition in force is theirs to state.
Participation changes which evidence transfers, and which edition of a harmonized guide the local instrument is likely to pin.