§ 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	🇹🇷Turkey	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	TİTCK	MHRA
English submissions	No	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	None	Available
Reference agencies	—	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — Ruhsat Başvurusu (Marketing Authorisation Application) · International Recognition Procedure (IRP)
Pathway name	Ruhsat Başvurusu (Marketing Authorisation Application)	International Recognition Procedure (IRP)
Approval timeline	210–540 days	60–110 days
Application fee	TRY 250,000	GBP 35,305
Annual renewal	TRY 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	A Turkish-resident Pharmacist (Sorumlu Müdür) registered with the Turkish Pharmacists Association (TEB) is mandatory for the importer/wholesaler licence. A separate Pharmacovigilance Officer (Farmakovijilans Sorumlusu) is required and must report to the Turkish Pharmacovigilance Centre (TÜFAM).	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 (Yetim İlaç), Conditional Approval (Şartlı Ruhsat) +1	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Post-approval variations classified into Type IA, IB, II, and Notification, aligned with EU Commission Regulation 1234/2008. TİTCK Variations Guideline (2017, updated) implements EU framework.	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 9 months before expiry. After first renewal, MA is granted for indefinite period (aligned with EU practice) unless safety concerns require subsequent renewal.	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	Turkish Pharmacovigilance Centre (TÜFAM, Türkiye Farmakovijilans Merkezi) under TİTCK. PSURs aligned with ICH E2C(R2). Mandatory ICSR reporting via TÜFAM electronic system. Turkey 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 + Turkish GCP Guidelines (2008, updated)	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	Yes	Yes
HTA body	Sağlık Hizmetleri Genel Müdürlüğü (Ministry of Health HTA Department) + SGK reimbursement evaluation	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

TurkeyTİTCK
United KingdomMHRA

English submissions

TurkeyNo
United KingdomYes

CTD accepted

TurkeyYes
United KingdomYes

eCTD accepted

TurkeyYes
United KingdomYes

Reliance pathway

TurkeyNone
United KingdomAvailable

Reference agencies

Turkey—
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — Ruhsat Başvurusu (Marketing Authorisation Application) · International Recognition Procedure (IRP)

Pathway name

TurkeyRuhsat Başvurusu (Marketing Authorisation Application)
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Turkey210–540 days
United Kingdom60–110 days

Application fee

TurkeyTRY 250,000
United KingdomGBP 35,305

Annual renewal

TurkeyTRY 50,000
United KingdomGBP 0

Local representative

TurkeyRequired
United KingdomNot required

Local manufacturing

TurkeyNot required
United KingdomNot required

GMP inspection

TurkeyRequired
United KingdomNot required

MAH & local presence

Local entity required

TurkeyYes
United KingdomYes

Local responsible person

TurkeyYes
United KingdomYes

RP role

TurkeyA Turkish-resident Pharmacist (Sorumlu Müdür) registered with the Turkish Pharmacists Association (TEB) is mandatory for the importer/wholesaler licence. A separate Pharmacovigilance Officer (Farmakovijilans Sorumlusu) is required and must report to the Turkish Pharmacovigilance Centre (TÜFAM).
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

Turkey4 designations
United Kingdom4 designations

Examples

TurkeyPriority Review, Orphan Drug Pathway (Yetim İlaç), Conditional Approval (Şartlı Ruhsat) +1
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

TurkeyPost-approval variations classified into Type IA, IB, II, and Notification, aligned with EU Commission Regulation 1234/2008. TİTCK Variations Guideline (2017, updated) implements EU framework.
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

TurkeyMarketing authorisations valid for 5 years; renewal required 9 months before expiry. After first renewal, MA is granted for indefinite period (aligned with EU practice) unless safety concerns require subsequent renewal.
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

TurkeyTurkish Pharmacovigilance Centre (TÜFAM, Türkiye Farmakovijilans Merkezi) under TİTCK. PSURs aligned with ICH E2C(R2). Mandatory ICSR reporting via TÜFAM electronic system. Turkey 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

TurkeyAvailable
United KingdomAvailable

Compassionate Use

TurkeyAvailable
United KingdomAvailable

Emergency Import

TurkeyAvailable
United KingdomAvailable

Parallel Import

TurkeyNot permitted
United KingdomPermitted

Clinical trials

CTA approval

TurkeyRequired
United KingdomRequired

Ethics approval

TurkeyYes
United KingdomYes

CTA timeline

Turkey60–90 days
United Kingdom30–60 days

GCP standard

TurkeyICH-GCP + Turkish GCP Guidelines (2008, updated)
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

TurkeyRegulated
United KingdomRegulated

Reference pricing

TurkeyYes
United KingdomNo

HTA required

TurkeyYes
United KingdomYes

HTA body

TurkeySağlık Hizmetleri Genel Müdürlüğü (Ministry of Health HTA Department) + SGK reimbursement evaluation
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)