Regulatory & legal instruments
JP·AU·NZ in-marketAMER·CA·EU·UKI·GL global · dashed
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pre-2020
Standing · the established base
JPJAS Act (agricultural standards)JPPMD Act (pharma & devices)NZMedicines Act 1981AUPrivacy Act 1988AUTherapeutic Goods Act 1989AUFood Standards ANZ Act 1991AUAgvet Chemicals Code Act 1994NZHazardous Substances & New Organisms Act 1996NZAnimal Products Act 1999AUGene Technology Act 2000NZAgricultural Compounds & Vet Medicines Act 1997NZWAND scheme (Medical Devices Regs 2003)JPCartagena Act (GMO / biodiversity)JPFIT / FIP renewable-electricity ActJPFood Labelling ActNZFood Act 2014AUTG priority + provisional approval pathwaysAUAI Ethics PrinciplesAUNational Electricity RulesGLPIC/S GMP mutual reliance
2020
JPSep 2020PMD Act IDATEN + conditional early approvalPMDAeffective
JPJun 2020Food Sanitation Act, mandatory HACCPMHLWeffective
JP2020DASH for SaMDMHLWeffective
NZDec 2020Privacy Act 2020OPCeffective
NZJul 2020Algorithm Charter for AotearoaStats NZeffective
AMER2020CMS hospital-at-home reimbursement waiverCMSeffective
CA2020Access Consortium reliance (Health Canada)Access Consortiumeffective
UKI2020UK MHRA reliance (Access Consortium)MHRAeffective
2021
AU2021FIRB national-security investment screeningTreasury / FIRBeffective
AUFeb 2021Software-as-a-medical-device regulationTGAeffective
2022
JPApr 2022APPI 2020 amendment (personal information)PPCeffective
JPAug 2022Economic Security Promotion Act (critical minerals)Cabinet Office / METIeffective
JPJan 2022METI AI Governance GuidelinesMETIeffective
AMER2022IRA Section 45X (domestic-content)US Treasury / IRSeffective
GL2022WHO Listed Authority tiersWHOeffective
2023
JPJun 2023GX Promotion ActMETIeffective
JPJan 2023METI Critical Minerals StrategyMETIeffective
JP2023PMDA AI/ML Medical Device GuidancePMDAeffective
AUDec 2023Food Standards Code 3.2.2A, food-safety toolsFSANZeffective
AUJun 2023Critical Minerals Strategy 2023-2030DISReffective
GL2023ICH Q13 continuous manufacturingICHeffective
2024
AUSep 2024Voluntary AI Safety Standard (no obligation)DISR / NAICeffective
NZSep 2024Critical Minerals List & StrategyMBIE / NZP&Meffective
AMERto Dec 2024FDA AI-enabled device authorisationsFDAeffective
EU2024EU AI Act (high-risk class)European Commissioneffective
EU2024EU Critical Raw Materials ActEuropean Commissioneffective
2025
JPSep 2025AI Promotion ActCabinet Office (AI Strategy HQ)effective
AUFeb 2025Critical Minerals Production Tax Incentive (CMPTI)Treasury / ATOtransitional
AUMar 2025AusUDID unique device identificationTGAeffective
AMERDec 2025BIOSECURE ActUS Congressenacted
2026
AUMar 2026Medical-device adverse-event reporting (ASDER)TGAeffective
2027
AUJul 2027CMPTI 10% offset claimableATOexpected
2028
AUApr 2028ASDER Stage 2 (medium-risk devices)TGAexpected
2029
·
2030
AU2030AusUDID full labelling milestoneTGAexpected
NZ~2030Medical Products regime (TP Act replacement)Medsafeexpected