§ 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 Kingdom
Authority & dossier
Regulatory authority	DGDA	MHRA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	None	Available
Reference agencies	FDA (US), EMA, MHRA (UK), Health Canada +4	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — New Drug Registration — Standard Review · International Recognition Procedure (IRP)
Pathway name	New Drug Registration — Standard Review	International Recognition Procedure (IRP)
Approval timeline	270–540 days	60–110 days
Application fee	BDT 100,000	GBP 35,305
Annual renewal	BDT 0	GBP 0
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Not required
MAH & local presence
Local entity required	Yes	Yes
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.	Qualified Person (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.
Accelerated pathways
Designations available	2 designations	4 designations
Examples	Emergency Use Authorisation (EUA), Priority DCC Review (Public Health Need)	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
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.	Variations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped variations across multiple authorisations.
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.	Initial 5-year renewal; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.
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.	MHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.
Unlicensed access
Named Patient Supply	Available	Available
Compassionate Use	Available	Available
Emergency Import	Available	Available
Parallel Import	Not permitted	Permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	60–150 days	30–60 days
GCP standard	ICH E6(R2) GCP; BMRC National Research Ethics Guidelines	ICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	No	No
HTA required	No	Yes
HTA body	No formal national HTA body; DGHS Essential Drug List (EDL) committee functions as the public-sector formulary gate.	NICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)

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

Authority & dossier

Regulatory authority

BangladeshDGDA
United KingdomMHRA

English submissions

BangladeshYes
United KingdomYes

CTD accepted

BangladeshYes
United KingdomYes

eCTD accepted

BangladeshNo
United KingdomYes

Reliance pathway

BangladeshNone
United KingdomAvailable

Reference agencies

BangladeshFDA (US), EMA, MHRA (UK), Health Canada +4
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — New Drug Registration — Standard Review · International Recognition Procedure (IRP)

Pathway name

BangladeshNew Drug Registration — Standard Review
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Bangladesh270–540 days
United Kingdom60–110 days

Application fee

BangladeshBDT 100,000
United KingdomGBP 35,305

Annual renewal

BangladeshBDT 0
United KingdomGBP 0

Local representative

BangladeshRequired
United KingdomNot required

Local manufacturing

BangladeshNot required
United KingdomNot required

GMP inspection

BangladeshRequired
United KingdomNot required

MAH & local presence

Local entity required

BangladeshYes
United KingdomYes

Local responsible person

BangladeshYes
United KingdomYes

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 KingdomQualified Person (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.

Accelerated pathways

Designations available

Bangladesh2 designations
United Kingdom4 designations

Examples

BangladeshEmergency Use Authorisation (EUA), Priority DCC Review (Public Health Need)
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

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 KingdomVariations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped variations across multiple authorisations.

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 KingdomInitial 5-year renewal; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.

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 KingdomMHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.

Unlicensed access

Named Patient Supply

BangladeshAvailable
United KingdomAvailable

Compassionate Use

BangladeshAvailable
United KingdomAvailable

Emergency Import

BangladeshAvailable
United KingdomAvailable

Parallel Import

BangladeshNot permitted
United KingdomPermitted

Clinical trials

CTA approval

BangladeshRequired
United KingdomRequired

Ethics approval

BangladeshYes
United KingdomYes

CTA timeline

Bangladesh60–150 days
United Kingdom30–60 days

GCP standard

BangladeshICH E6(R2) GCP; BMRC National Research Ethics Guidelines
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

BangladeshRegulated
United KingdomRegulated

Reference pricing

BangladeshNo
United KingdomNo

HTA required

BangladeshNo
United KingdomYes

HTA body

BangladeshNo formal national HTA body; DGHS Essential Drug List (EDL) committee functions as the public-sector formulary gate.
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)