§ 02 — Comparison

Compare regulatory pathways side-by-side

Benchmark MAHMAH, GMPGMP, HTAHTA and pathway requirements across up to three markets.

Country A

Country B

Country C

Highlight differences

Criterion	🇦🇺Australia	🇺🇸United States
Authority & dossier
Regulatory authority	TGA	FDA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	None
Reference agencies	FDA, EMA, MHRA, Health Canada +2	—
Lead pathway (timeline & fees) — Standard Prescription Medicine Registration · New Drug Application — 505(b)(1)
Pathway name	Standard Prescription Medicine Registration	New Drug Application — 505(b)(1)
Approval timeline	220–255 days	304–365 days
Application fee	AUD 273,700	USD 4,310,002
Annual renewal	AUD 4,490	USD 416,734
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Required
MAH & local presence
Local entity required	Yes	No
Local responsible person	Yes	Yes
RP role	Authorised Person for Pharmacovigilance: Australian-resident contact responsible for pharmacovigilance, periodic safety reporting, and TGA correspondence.	US Agent: a person residing or maintaining a place of business in the US, designated to act on behalf of the foreign establishment for FDA communications, including notification of inspections.
Accelerated pathways
Designations available	3 designations	6 designations
Examples	Priority Review Designation, Provisional Approval, Orphan Drug Designation	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
Post-approval lifecycle
Variations framework	Variations to ARTG entries follow a Type-classified system (Self-Assessable Notifications, Minor Variations, Notifications, and Major Variations) broadly aligned with EU classification.	FDA classifies post-approval changes as: Annual Reportable, Changes Being Effected (CBE-0 immediate, CBE-30 with 30-day pre-implementation notice), and Prior Approval Supplements (PAS) — the most significant changes requiring FDA approval before implementation. Major manufacturing or labelling changes typically require a PAS.
Renewal cycle	ARTG entries do not formally expire but require payment of the annual entry fee (AUD 4,490 per registration). Failure to pay results in cancellation. No fixed renewal cycle.	FDA does not require periodic renewal of NDAs or BLAs — approvals remain in effect indefinitely subject to compliance, payment of annual program fees, and post-marketing requirements. Annual reports are required.
Pharmacovigilance	Sponsors must maintain a Pharmacovigilance System Master File equivalent and report ADRs to TGA. PBRERs follow ICH E2C(R2). Black Triangle scheme applies to selected new medicines requiring intensive monitoring.	Mandatory expedited reporting of serious unexpected ADRs within 15 calendar days; periodic safety reports (PADERs/PAERs) for the first 3 years post-approval, then annually. PSURs in ICH E2C(R2) format accepted in lieu of PADERs by agreement. FAERS database receives spontaneous reports. Post-Marketing Requirements (PMRs) and Commitments (PMCs) tracked publicly.
Unlicensed access
Named Patient Supply	Available	Available
Compassionate Use	Available	Available
Emergency Import	Available	Available
Parallel Import	Not permitted	Not permitted
Clinical trials
CTA approval	Notification	Required
Ethics approval	Yes	Yes
CTA timeline	14–60 days	30–30 days
GCP standard	ICH-GCP E6(R3) (adopted 2026)	ICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
Pricing & reimbursement
Price regulation	Regulated	Free pricing
Reference pricing	Yes	No
HTA required	Yes	No
HTA body	Pharmaceutical Benefits Advisory Committee (PBAC)	ICER (Institute for Clinical and Economic Review) — independent, non-binding

Verdict colours indicate lower, moderate, or higher regulatory burden — they're not value judgements on a market.

Authority & dossier

Regulatory authority

AustraliaTGA
United StatesFDA

English submissions

AustraliaYes
United StatesYes

CTD accepted

AustraliaYes
United StatesYes

eCTD accepted

AustraliaYes
United StatesYes

Reliance pathway

AustraliaAvailable
United StatesNone

Reference agencies

AustraliaFDA, EMA, MHRA, Health Canada +2
United States—

Lead pathway (timeline & fees) — Standard Prescription Medicine Registration · New Drug Application — 505(b)(1)

Pathway name

AustraliaStandard Prescription Medicine Registration
United StatesNew Drug Application — 505(b)(1)

Approval timeline

Australia220–255 days
United States304–365 days

Application fee

AustraliaAUD 273,700
United StatesUSD 4,310,002

Annual renewal

AustraliaAUD 4,490
United StatesUSD 416,734

Local representative

AustraliaRequired
United StatesNot required

Local manufacturing

AustraliaNot required
United StatesNot required

GMP inspection

AustraliaRequired
United StatesRequired

MAH & local presence

Local entity required

AustraliaYes
United StatesNo

Local responsible person

AustraliaYes
United StatesYes

RP role

AustraliaAuthorised Person for Pharmacovigilance: Australian-resident contact responsible for pharmacovigilance, periodic safety reporting, and TGA correspondence.
United StatesUS Agent: a person residing or maintaining a place of business in the US, designated to act on behalf of the foreign establishment for FDA communications, including notification of inspections.

Accelerated pathways

Designations available

Australia3 designations
United States6 designations

Examples

AustraliaPriority Review Designation, Provisional Approval, Orphan Drug Designation
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3

Post-approval lifecycle

Variations framework

AustraliaVariations to ARTG entries follow a Type-classified system (Self-Assessable Notifications, Minor Variations, Notifications, and Major Variations) broadly aligned with EU classification.
United StatesFDA classifies post-approval changes as: Annual Reportable, Changes Being Effected (CBE-0 immediate, CBE-30 with 30-day pre-implementation notice), and Prior Approval Supplements (PAS) — the most significant changes requiring FDA approval before implementation. Major manufacturing or labelling changes typically require a PAS.

Renewal cycle

AustraliaARTG entries do not formally expire but require payment of the annual entry fee (AUD 4,490 per registration). Failure to pay results in cancellation. No fixed renewal cycle.
United StatesFDA does not require periodic renewal of NDAs or BLAs — approvals remain in effect indefinitely subject to compliance, payment of annual program fees, and post-marketing requirements. Annual reports are required.

Pharmacovigilance

AustraliaSponsors must maintain a Pharmacovigilance System Master File equivalent and report ADRs to TGA. PBRERs follow ICH E2C(R2). Black Triangle scheme applies to selected new medicines requiring intensive monitoring.
United StatesMandatory expedited reporting of serious unexpected ADRs within 15 calendar days; periodic safety reports (PADERs/PAERs) for the first 3 years post-approval, then annually. PSURs in ICH E2C(R2) format accepted in lieu of PADERs by agreement. FAERS database receives spontaneous reports. Post-Marketing Requirements (PMRs) and Commitments (PMCs) tracked publicly.

Unlicensed access

Named Patient Supply

AustraliaAvailable
United StatesAvailable

Compassionate Use

AustraliaAvailable
United StatesAvailable

Emergency Import

AustraliaAvailable
United StatesAvailable

Parallel Import

AustraliaNot permitted
United StatesNot permitted

Clinical trials

CTA approval

AustraliaNotification
United StatesRequired

Ethics approval

AustraliaYes
United StatesYes

CTA timeline

Australia14–60 days
United States30–30 days

GCP standard

AustraliaICH-GCP E6(R3) (adopted 2026)
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56

Pricing & reimbursement

Price regulation

AustraliaRegulated
United StatesFree pricing

Reference pricing

AustraliaYes
United StatesNo

HTA required

AustraliaYes
United StatesNo

HTA body

AustraliaPharmaceutical Benefits Advisory Committee (PBAC)
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding