§ 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	🇦🇪United Arab Emirates	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	MoHAP	MHRA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA (centralised), MHRA, Health Canada +3	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — Federal Drug Registration (Standard) · International Recognition Procedure (IRP)
Pathway name	Federal Drug Registration (Standard)	International Recognition Procedure (IRP)
Approval timeline	180–365 days	60–110 days
Application fee	AED 8,500	GBP 35,305
Annual renewal	AED 5,000	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	A UAE-resident Registered Pharmacist must be designated as Responsible Pharmacist for the Drug Store Licence. A separate Pharmacovigilance Officer is required and must report to MoHAP Pharmacovigilance.	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	4 designations	4 designations
Examples	Priority Review, Orphan Drug Pathway, Pandemic Emergency Use Authorisation +1	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Post-approval variations broadly aligned with EU Type IA/IB/II framework. Major variations require MoHAP approval; Minor follow tacit-approval procedures.	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	Marketing authorisations valid for 5 years; renewal required 6 months before expiry. Renewal includes updated PSUR, sales data, and pharmacovigilance summary.	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	MoHAP Pharmacovigilance Department; PSURs aligned with ICH E2C(R2). Mandatory ICSR reporting via the National Pharmacovigilance Centre. UAE is a WHO-UMC member.	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	60–90 days	30–60 days
GCP standard	ICH-GCP	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	Yes	No
HTA required	No	Yes
HTA body	Emerging — DoH and DHA developing emirate-level HTA; no federal HTA agency yet	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

United Arab EmiratesMoHAP
United KingdomMHRA

English submissions

United Arab EmiratesYes
United KingdomYes

CTD accepted

United Arab EmiratesYes
United KingdomYes

eCTD accepted

United Arab EmiratesYes
United KingdomYes

Reliance pathway

United Arab EmiratesAvailable
United KingdomAvailable

Reference agencies

United Arab EmiratesFDA, EMA (centralised), MHRA, Health Canada +3
United KingdomFDA, EMA, Health Canada, Swissmedic +4

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

Pathway name

United Arab EmiratesFederal Drug Registration (Standard)
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

United Arab Emirates180–365 days
United Kingdom60–110 days

Application fee

United Arab EmiratesAED 8,500
United KingdomGBP 35,305

Annual renewal

United Arab EmiratesAED 5,000
United KingdomGBP 0

Local representative

United Arab EmiratesRequired
United KingdomNot required

Local manufacturing

United Arab EmiratesNot required
United KingdomNot required

GMP inspection

United Arab EmiratesRequired
United KingdomNot required

MAH & local presence

Local entity required

United Arab EmiratesYes
United KingdomYes

Local responsible person

United Arab EmiratesYes
United KingdomYes

RP role

United Arab EmiratesA UAE-resident Registered Pharmacist must be designated as Responsible Pharmacist for the Drug Store Licence. A separate Pharmacovigilance Officer is required and must report to MoHAP Pharmacovigilance.
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

United Arab Emirates4 designations
United Kingdom4 designations

Examples

United Arab EmiratesPriority Review, Orphan Drug Pathway, Pandemic Emergency Use Authorisation +1
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

United Arab EmiratesPost-approval variations broadly aligned with EU Type IA/IB/II framework. Major variations require MoHAP approval; Minor follow tacit-approval procedures.
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

United Arab EmiratesMarketing authorisations valid for 5 years; renewal required 6 months before expiry. Renewal includes updated PSUR, sales data, and pharmacovigilance summary.
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

United Arab EmiratesMoHAP Pharmacovigilance Department; PSURs aligned with ICH E2C(R2). Mandatory ICSR reporting via the National Pharmacovigilance Centre. UAE is a WHO-UMC member.
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

United Arab EmiratesAvailable
United KingdomAvailable

Compassionate Use

United Arab EmiratesAvailable
United KingdomAvailable

Emergency Import

United Arab EmiratesAvailable
United KingdomAvailable

Parallel Import

United Arab EmiratesNot permitted
United KingdomPermitted

Clinical trials

CTA approval

United Arab EmiratesRequired
United KingdomRequired

Ethics approval

United Arab EmiratesYes
United KingdomYes

CTA timeline

United Arab Emirates60–90 days
United Kingdom30–60 days

GCP standard

United Arab EmiratesICH-GCP
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

United Arab EmiratesRegulated
United KingdomRegulated

Reference pricing

United Arab EmiratesYes
United KingdomNo

HTA required

United Arab EmiratesNo
United KingdomYes

HTA body

United Arab EmiratesEmerging — DoH and DHA developing emirate-level HTA; no federal HTA agency yet
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)