§ 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	🇧🇩Bangladesh	🇺🇸United States
Authority & dossier
Regulatory authority	DGDA	FDA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	None	None
Reference agencies	FDA (US), EMA, MHRA (UK), Health Canada +4	—
Lead pathway (timeline & fees) — New Drug Registration — Standard Review · New Drug Application — 505(b)(1)
Pathway name	New Drug Registration — Standard Review	New Drug Application — 505(b)(1)
Approval timeline	270–540 days	304–365 days
Application fee	BDT 100,000	USD 4,310,002
Annual renewal	BDT 0	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	Importers must designate a Qualified Person (typically a registered pharmacist) responsible for the licensed premises, and a pharmacovigilance contact person responsible for ADR reporting and PSUR submissions to DGDA's Adverse Drug Reaction Monitoring (ADRM) Cell.	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	2 designations	6 designations
Examples	Emergency Use Authorisation (EUA), Priority DCC Review (Public Health Need)	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
Post-approval lifecycle
Variations framework	Variations are classified in DGDA guidance as Major (DCC approval, e.g. new indication, new strength, manufacturing site change), Minor (DGDA approval) and Notification (administrative). Major variations require fresh DCC consideration and may take 3–9 months.	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	Drug Registration Certificate (Form 1A) is initially valid for 5 years and renewable for 5 years; renewal requires up-to-date CMC, safety, GMP and labelling information.	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	DGDA's Adverse Drug Reaction Monitoring (ADRM) Cell coordinates national ADR reporting; Bangladesh is a member of the WHO Programme for International Drug Monitoring (Uppsala Monitoring Centre). Registration holders must report serious ADRs within statutory timelines and submit Periodic Safety Update Reports (PSURs) per DGDA guidance, generally aligned to ICH E2C.	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	Required	Required
Ethics approval	Yes	Yes
CTA timeline	60–150 days	30–30 days
GCP standard	ICH E6(R2) GCP; BMRC National Research Ethics Guidelines	ICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
Pricing & reimbursement
Price regulation	Regulated	Free pricing
Reference pricing	No	No
HTA required	No	No
HTA body	No formal national HTA body; DGHS Essential Drug List (EDL) committee functions as the public-sector formulary gate.	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

BangladeshDGDA
United StatesFDA

English submissions

BangladeshYes
United StatesYes

CTD accepted

BangladeshYes
United StatesYes

eCTD accepted

BangladeshNo
United StatesYes

Reliance pathway

BangladeshNone
United StatesNone

Reference agencies

BangladeshFDA (US), EMA, MHRA (UK), Health Canada +4
United States—

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

Pathway name

BangladeshNew Drug Registration — Standard Review
United StatesNew Drug Application — 505(b)(1)

Approval timeline

Bangladesh270–540 days
United States304–365 days

Application fee

BangladeshBDT 100,000
United StatesUSD 4,310,002

Annual renewal

BangladeshBDT 0
United StatesUSD 416,734

Local representative

BangladeshRequired
United StatesNot required

Local manufacturing

BangladeshNot required
United StatesNot required

GMP inspection

BangladeshRequired
United StatesRequired

MAH & local presence

Local entity required

BangladeshYes
United StatesNo

Local responsible person

BangladeshYes
United StatesYes

RP role

BangladeshImporters must designate a Qualified Person (typically a registered pharmacist) responsible for the licensed premises, and a pharmacovigilance contact person responsible for ADR reporting and PSUR submissions to DGDA's Adverse Drug Reaction Monitoring (ADRM) Cell.
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

Bangladesh2 designations
United States6 designations

Examples

BangladeshEmergency Use Authorisation (EUA), Priority DCC Review (Public Health Need)
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3

Post-approval lifecycle

Variations framework

BangladeshVariations are classified in DGDA guidance as Major (DCC approval, e.g. new indication, new strength, manufacturing site change), Minor (DGDA approval) and Notification (administrative). Major variations require fresh DCC consideration and may take 3–9 months.
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

BangladeshDrug Registration Certificate (Form 1A) is initially valid for 5 years and renewable for 5 years; renewal requires up-to-date CMC, safety, GMP and labelling information.
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

BangladeshDGDA's Adverse Drug Reaction Monitoring (ADRM) Cell coordinates national ADR reporting; Bangladesh is a member of the WHO Programme for International Drug Monitoring (Uppsala Monitoring Centre). Registration holders must report serious ADRs within statutory timelines and submit Periodic Safety Update Reports (PSURs) per DGDA guidance, generally aligned to ICH E2C.
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

BangladeshAvailable
United StatesAvailable

Compassionate Use

BangladeshAvailable
United StatesAvailable

Emergency Import

BangladeshAvailable
United StatesAvailable

Parallel Import

BangladeshNot permitted
United StatesNot permitted

Clinical trials

CTA approval

BangladeshRequired
United StatesRequired

Ethics approval

BangladeshYes
United StatesYes

CTA timeline

Bangladesh60–150 days
United States30–30 days

GCP standard

BangladeshICH E6(R2) GCP; BMRC National Research Ethics Guidelines
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56

Pricing & reimbursement

Price regulation

BangladeshRegulated
United StatesFree pricing

Reference pricing

BangladeshNo
United StatesNo

HTA required

BangladeshNo
United StatesNo

HTA body

BangladeshNo formal national HTA body; DGHS Essential Drug List (EDL) committee functions as the public-sector formulary gate.
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding