§ 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	🇵🇰Pakistan	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	DRAP	MHRA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	Available	Available
Reference agencies	FDA (US), EMA, MHRA (UK), Health Canada +4	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — Standard Registration (Form 5/5F) — Imported / Locally Manufactured · International Recognition Procedure (IRP)
Pathway name	Standard Registration (Form 5/5F) — Imported / Locally Manufactured	International Recognition Procedure (IRP)
Approval timeline	365–730 days	60–110 days
Application fee	PKR 500,000	GBP 35,305
Annual renewal	PKR 50,000	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	Registration certificate holders must designate a qualified person (typically a pharmacist registered with the Pharmacy Council of Pakistan) for technical / pharmacovigilance correspondence with DRAP.	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	1 designation	4 designations
Examples	Public Health Emergency / Critical Need Registration	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Variations classified into major (require Registration Board approval — e.g., new indication, formulation change, new manufacturing site) and minor (notification). Pricing variations follow the Drug Pricing Policy and require separate Pricing Committee approval.	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	Registration is valid for 5 years and must be renewed before expiry, with up-to-date CMC, safety and pricing 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	DRAP's Pharmacovigilance Centre coordinates national ADR reporting (member of WHO Programme for International Drug Monitoring, Uppsala). Marketing authorisation holders must submit PSURs aligned to ICH E2C(R2), report serious ADRs within statutory timelines, and maintain a Risk Management Plan for new active substances.	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	60–180 days	30–60 days
GCP standard	ICH E6(R2) GCP; DRAP Bio-Study Rules and Good Clinical Practice 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	Yes	No
HTA required	No	Yes
HTA body	No formal national HTA body; DRAP Pricing Committee makes pricing decisions	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

PakistanDRAP
United KingdomMHRA

English submissions

PakistanYes
United KingdomYes

CTD accepted

PakistanYes
United KingdomYes

eCTD accepted

PakistanNo
United KingdomYes

Reliance pathway

PakistanAvailable
United KingdomAvailable

Reference agencies

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

Lead pathway (timeline & fees) — Standard Registration (Form 5/5F) — Imported / Locally Manufactured · International Recognition Procedure (IRP)

Pathway name

PakistanStandard Registration (Form 5/5F) — Imported / Locally Manufactured
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Pakistan365–730 days
United Kingdom60–110 days

Application fee

PakistanPKR 500,000
United KingdomGBP 35,305

Annual renewal

PakistanPKR 50,000
United KingdomGBP 0

Local representative

PakistanRequired
United KingdomNot required

Local manufacturing

PakistanNot required
United KingdomNot required

GMP inspection

PakistanRequired
United KingdomNot required

MAH & local presence

Local entity required

PakistanYes
United KingdomYes

Local responsible person

PakistanYes
United KingdomYes

RP role

PakistanRegistration certificate holders must designate a qualified person (typically a pharmacist registered with the Pharmacy Council of Pakistan) for technical / pharmacovigilance correspondence with DRAP.
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

Pakistan1 designation
United Kingdom4 designations

Examples

PakistanPublic Health Emergency / Critical Need Registration
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

PakistanVariations classified into major (require Registration Board approval — e.g., new indication, formulation change, new manufacturing site) and minor (notification). Pricing variations follow the Drug Pricing Policy and require separate Pricing Committee approval.
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

PakistanRegistration is valid for 5 years and must be renewed before expiry, with up-to-date CMC, safety and pricing 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

PakistanDRAP's Pharmacovigilance Centre coordinates national ADR reporting (member of WHO Programme for International Drug Monitoring, Uppsala). Marketing authorisation holders must submit PSURs aligned to ICH E2C(R2), report serious ADRs within statutory timelines, and maintain a Risk Management Plan for new active substances.
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

PakistanAvailable
United KingdomAvailable

Compassionate Use

PakistanAvailable
United KingdomAvailable

Emergency Import

PakistanAvailable
United KingdomAvailable

Parallel Import

PakistanNot permitted
United KingdomPermitted

Clinical trials

CTA approval

PakistanRequired
United KingdomRequired

Ethics approval

PakistanYes
United KingdomYes

CTA timeline

Pakistan60–180 days
United Kingdom30–60 days

GCP standard

PakistanICH E6(R2) GCP; DRAP Bio-Study Rules and Good Clinical Practice Guidelines
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

PakistanRegulated
United KingdomRegulated

Reference pricing

PakistanYes
United KingdomNo

HTA required

PakistanNo
United KingdomYes

HTA body

PakistanNo formal national HTA body; DRAP Pricing Committee makes pricing decisions
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)