[ THE FIFTH AXIS ]

Where it binds, and at which version.

A jurisdiction does not only decide which requirements apply. It decides which version of a harmonized instrument binds — Argentina adopts one edition of the PIC/S Guide where Australia adopts another, so “PIC/S-aligned” is not one standard across markets.

What this axis does not claim

Coverage is partial by design: it spans the jurisdictions SPEQ has decoded a body or an instrument for, and says so rather than padding the list. Confirm the current instrument and its in-force version with the authority before relying on it.

How to use this library

Start with where you intend to sell. Each card counts the authorities operating there and the standards SPEQ decodes for them; where a jurisdiction has taken a harmonized guide into its own law, the page behind it names the edition that was pinned.

Nothing is sold into a harmonizer — its output binds only where a national authority adopts it, at the edition that authority pinned. SPEQ decodes where a requirement binds; it does not determine what applies to your product, and an adopted version can move without this page moving with it.

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30 jurisdictions

Most decoded

USUnited StatesStatutory requirements written directly into federal regulation, enforced by inspection and by published enforcement action.6regulators66standardsICHPIC/SNorth America

ICHHARMONIZERProduces the guidelines member authorities implement in their own law. Nothing is sold into ICH; its output arrives through a national regulator adopting it.1bodies28standards10marketsNot a market

European UnionA single market whose requirements are set centrally and applied by national competent authorities — so the rule is common and the inspectorate is not.2regulators27standardsICHPIC/SEurope

WHOHARMONIZERPublishes technical reports and prequalification standards that national authorities take up by reference rather than apply directly.1bodies7standards0marketsNot a market

PIC/SHARMONIZERA co-operation scheme between inspectorates. Membership is what makes an inspection outcome travel — and each member pins its own version of the Guide.1bodies4standards16marketsNot a market

GBUnited KingdomA post-EU-exit regime that retained EU-derived requirements and now diverges from them selectively.1regulators3standardsICHPIC/SEurope

JPJapanA ministry setting the requirements and an agency conducting the scientific review and inspection.2regulators3standardsICHPIC/SAsia-Pacific

CNChinaA national authority with its own GMP and its own registration pathway, converging on ICH since accession.1regulators3standardsICHAsia-Pacific

VICHHARMONIZERThe veterinary counterpart to ICH, harmonising the technical requirements that apply to veterinary medicinal products.1bodies3standards0marketsNot a market

CACanadaA single federal health authority licensing establishments and inspecting against its own GMP guide.1regulators2standardsICHPIC/SNorth America

INIndiaA central authority alongside state licensing, with GMP set out in the schedule to national drug rules.2regulators2standardsAsia-Pacific

Council of EuropeHARMONIZERHome of the European Pharmacopoeia, which is legally binding in signatory states — the case where a harmonizer output binds directly rather than by national adoption.1bodies2standards0marketsNot a market

IMDRFHARMONIZERA forum of device regulators producing the vocabulary and the risk framework that device submissions are actually written in.1bodies2standards0marketsNot a market

CHSwitzerlandOutside the EU single market, inside the European regulatory conversation through mutual recognition.1regulators1standardsICHPIC/SEurope

AUAustraliaEnacts GMP by reference: a Determination adopts a named PIC/S Guide version as the Manufacturing Principles a licensed manufacturer must meet.1regulators1standards1pinnedICHPIC/SAsia-Pacific

KRSouth KoreaA single ministry-level authority for food and drug safety, participating in the main harmonizers.1regulators1standardsICHPIC/SAsia-Pacific

BRBrazilA national sanitary surveillance agency with its own resolutions and inspection programme.1regulators1standardsICHPIC/SLatin America

MXMexicoA federal commission for protection against sanitary risk, operating through official Mexican standards.1regulators1standardsLatin America

ARArgentinaA national administration whose consolidated GMP guide names the international sources it adopts, and the version of each.1regulators1standards1pinnedPIC/SLatin America

COColombiaA national institute for medicine and food surveillance, licensing manufacturers and inspecting them against its own resolutions.1regulators1standardsLatin America

PEPeruA directorate-general for medicines, supplies and drugs sitting inside the health ministry rather than beside it.1regulators1standardsLatin America

CLChileA public health institute that holds the national medicines authority function alongside its laboratory role.1regulators1standardsLatin America

SGSingaporeA health sciences authority that combines product regulation with forensic science and national blood services under one roof.1regulators1standardsPIC/SAsia-Pacific

TWTaiwanA food and drug administration operating a PIC/S-aligned inspection programme across medicines and food.1regulators1standardsPIC/SAsia-Pacific

THThailandA national food and drug administration licensing both manufacturers and importers, with a PIC/S-aligned inspectorate.1regulators1standardsPIC/SAsia-Pacific

MYMalaysiaA national pharmaceutical regulatory agency sitting within the health ministry, registering products and licensing manufacture.1regulators1standardsPIC/SAsia-Pacific

SASaudi ArabiaA food and drug authority regulating medicines, devices and food under a single body rather than three.1regulators1standardsPIC/SMiddle East & Africa

ZASouth AfricaA health products regulatory authority that licenses manufacturers and runs its own inspection programme.1regulators1standardsPIC/SMiddle East & Africa

United States (state level)Where a compounding pharmacy is actually regulated: the state board licenses and inspects it, and state adoption is what gives compendial chapters legal force.1regulators1standardsNorth America

Codex AlimentariusHARMONIZERThe joint FAO and WHO food standards programme, referenced into national food law rather than applied to anyone directly.1bodies1standards0marketsNot a market

COMPLETE INDEX — ALL 30 JURISDICTION

Counts derive at render from the bodies each jurisdiction names and the standards those bodies carry. Coverage is partial by design — it spans the jurisdictions SPEQ has decoded a body or an instrument for, and a missing adoption edge is a gap in this catalog rather than a finding about a country.