§ 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	🇲🇾Malaysia	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	NPRA	MHRA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	FDA (US), EMA, MHRA (UK), Health Canada +5	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — Full Evaluation — New Drug Product (NCE / new biologic) · International Recognition Procedure (IRP)
Pathway name	Full Evaluation — New Drug Product (NCE / new biologic)	International Recognition Procedure (IRP)
Approval timeline	245–365 days	60–110 days
Application fee	MYR 1,000	GBP 35,305
Annual renewal	MYR 500	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	PRHs must designate a registered pharmacist (under the Registration of Pharmacists Act 1951) as the responsible person for the licensed premises, and a Qualified Person for Pharmacovigilance (QPPV) who is the contact for NPRA's Pharmacovigilance Section.	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	Facilitated Registration Pathway (FRP), Conditional Registration / Public Health Emergency	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Variations classified per the DRGD into Major Variation (MaV — DCA approval), Minor Variation (MiV-PA prior approval, MiV-N notification) and Administrative Variation. Aligned with ASEAN Variation Guideline.	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 is valid for 5 years and must be renewed before expiry, with up-to-date CMC, safety 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	NPRA's Pharmacovigilance Section coordinates national ADR reporting (Malaysia is a member of the WHO Programme for International Drug Monitoring, Uppsala). PRHs must submit PSURs aligned to ICH E2C(R2), report serious ADRs within statutory timelines, and maintain a Risk Management Plan (RMP) for new active substances. NPRA publishes safety alerts via MADRAC (Malaysian Adverse Drug Reactions Advisory Committee).	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	30–60 days	30–60 days
GCP standard	ICH E6(R2/R3) GCP; Malaysian Guideline for Good Clinical Practice	ICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)
Pricing & reimbursement
Price regulation	Free pricing	Regulated
Reference pricing	No	No
HTA required	Yes	Yes
HTA body	MaHTAS — Malaysian Health Technology Assessment Section, Ministry of Health	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

MalaysiaNPRA
United KingdomMHRA

English submissions

MalaysiaYes
United KingdomYes

CTD accepted

MalaysiaYes
United KingdomYes

eCTD accepted

MalaysiaYes
United KingdomYes

Reliance pathway

MalaysiaAvailable
United KingdomAvailable

Reference agencies

MalaysiaFDA (US), EMA, MHRA (UK), Health Canada +5
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — Full Evaluation — New Drug Product (NCE / new biologic) · International Recognition Procedure (IRP)

Pathway name

MalaysiaFull Evaluation — New Drug Product (NCE / new biologic)
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Malaysia245–365 days
United Kingdom60–110 days

Application fee

MalaysiaMYR 1,000
United KingdomGBP 35,305

Annual renewal

MalaysiaMYR 500
United KingdomGBP 0

Local representative

MalaysiaRequired
United KingdomNot required

Local manufacturing

MalaysiaNot required
United KingdomNot required

GMP inspection

MalaysiaRequired
United KingdomNot required

MAH & local presence

Local entity required

MalaysiaYes
United KingdomYes

Local responsible person

MalaysiaYes
United KingdomYes

RP role

MalaysiaPRHs must designate a registered pharmacist (under the Registration of Pharmacists Act 1951) as the responsible person for the licensed premises, and a Qualified Person for Pharmacovigilance (QPPV) who is the contact for NPRA's Pharmacovigilance Section.
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

Malaysia2 designations
United Kingdom4 designations

Examples

MalaysiaFacilitated Registration Pathway (FRP), Conditional Registration / Public Health Emergency
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

MalaysiaVariations classified per the DRGD into Major Variation (MaV — DCA approval), Minor Variation (MiV-PA prior approval, MiV-N notification) and Administrative Variation. Aligned with ASEAN Variation Guideline.
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

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

MalaysiaNPRA's Pharmacovigilance Section coordinates national ADR reporting (Malaysia is a member of the WHO Programme for International Drug Monitoring, Uppsala). PRHs must submit PSURs aligned to ICH E2C(R2), report serious ADRs within statutory timelines, and maintain a Risk Management Plan (RMP) for new active substances. NPRA publishes safety alerts via MADRAC (Malaysian Adverse Drug Reactions Advisory Committee).
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

MalaysiaAvailable
United KingdomAvailable

Compassionate Use

MalaysiaAvailable
United KingdomAvailable

Emergency Import

MalaysiaAvailable
United KingdomAvailable

Parallel Import

MalaysiaNot permitted
United KingdomPermitted

Clinical trials

CTA approval

MalaysiaRequired
United KingdomRequired

Ethics approval

MalaysiaYes
United KingdomYes

CTA timeline

Malaysia30–60 days
United Kingdom30–60 days

GCP standard

MalaysiaICH E6(R2/R3) GCP; Malaysian Guideline for Good Clinical Practice
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

MalaysiaFree pricing
United KingdomRegulated

Reference pricing

MalaysiaNo
United KingdomNo

HTA required

MalaysiaYes
United KingdomYes

HTA body

MalaysiaMaHTAS — Malaysian Health Technology Assessment Section, Ministry of Health
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)