[ NATIONAL · AU ]
Enacts GMP by reference: a Determination adopts a named PIC/S Guide version as the Manufacturing Principles a licensed manufacturer must meet.
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 Therapeutic Goods Act 1989 (No. 21, 1990), which regulates medicines, medical devices and biologicals through registration, listing and compliance. Its distinctive move is section 36, which provides for “Manufacturing principles” — the Act does not write GMP into statute but empowers a determination to name the standard that manufacturers must meet. Standards for therapeutic goods generally are determined under section 10; medical devices have their own structure in the Essential principles at section 41CA and medical device standards at section 41CB.
By reference, and that is the whole architecture. A determination made under the Act adopts a named edition of the PIC/S Guide as the Manufacturing Principles, so the binding text is an external document identified by version — which is why this page states an edition rather than a name. Non-compliance is not treated as a paperwork matter: the Act attaches both criminal offences and civil penalties, at sections 14 and 14A and at sections 35 and 35A. The TGA has been a PIC/S Participating Authority since November 1995, in the founding cohort of the Scheme.
WHAT TRANSFERS
Inspection confidence transfers; the pinned edition does not travel with it. Australia is the clearest illustration of why this axis is typed rather than stored as a string: two PIC/S participating authorities can adopt different editions of the same guide, so a site assessed against one edition has not thereby been assessed against another. The question to ask before relying on any evidence prepared elsewhere is not whether the origin is a PIC/S member but which edition its determination currently names — and that is a fact about the determination, not about the membership.
Section 36 is a power to determine, not a standard. Reading the Act for the requirement produces nothing useful; the requirement lives in the instrument the Act points at, and that instrument names an external guide at a specific edition.
Essential principles (section 41CA) and medical device standards (section 41CB) are a different structure from the Manufacturing Principles that govern medicines. An organisation spanning both is complying with two mechanisms in one Act.
Sections 14, 14A, 35 and 35A create both. The practical consequence is that regulatory exposure here is not limited to prosecution, and the risk conversation should not be framed as though it were.
The Act separates registration from listing, and compliance obligations attach to the approval a product actually holds. Assuming one pathway’s obligations apply to the other is a common and consequential error.
The Therapeutic Goods Act 1989, No. 21 of 1990. Section 36 provides for Manufacturing principles, section 10 for standards for therapeutic goods generally, and sections 41CA and 41CB for the Essential principles and medical device standards that govern devices.
Not in the Act. Section 36 empowers a determination that adopts a named edition of the PIC/S Guide to GMP as the Manufacturing Principles, so the binding requirement sits in an external document identified by version. The edition currently adopted is the fact that matters, and it is stated on this page rather than described.
The Act attaches both criminal offences and civil penalties — at sections 14 and 14A, and at sections 35 and 35A. Regulatory exposure in Australia is therefore not confined to prosecution, which is how it is often described.
Yes. The Therapeutic Goods Administration has been a PIC/S Participating Authority since November 1995, in the Scheme’s founding cohort. That supports mutual confidence in inspection outcomes; it does not mean Australia and another member have adopted the same edition of the Guide.
ADOPTED, AT A PINNED VERSION
PIC/S PE 009-17 of 25 August 2023
Excludes Annexes 4, 5 and 14, and makes the Guide’s "should" statements mandatory unless departure can be justified to a TGA officer. The Annex 1 clauses 2.1, 2.3, 7.14 and 9.31 applied to sterile manufacture only from 1 March 2026.
Participation changes which evidence transfers, and which edition of a harmonized guide the local instrument is likely to pin.