PV Bulletin

Innovative Licensing and Access Pathway (ILAP) Guidance Updates

The MHRA has updated the guidance for the Innovative Licensing and Access Pathway (ILAP), revising key sections and application round dates.

Primary source: ILAP application guidance

PV Impact Brief

Urgency: HighConfidence: high

What changed

Guidance on the Target Development Profile (TDP) and Joint Scientific Advice (JSA) sections of the ILAP has been revised, with new application round dates provided for subsequent rounds.

Why it matters

These changes require sponsors to adapt their development strategies accordingly, ensuring that safety and scientific advice are integrated into the accelerated access pathway, thereby potentially reducing time to market for transformative therapies.

Action needed

Sponsors in the ILAP must update their Target Development Profiles to reflect the revised TDP and coordinate closely with pharmacovigilance teams for alignment with the new roadmap.

Relevant for
Regulatory Intelligence LeadSignal Management LeadLabeling Lead
Processes impacted
Signal ManagementLabeling
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Policy change details

Document type
Guidance
Policy status
revised
Publication date
2026-08-05
Policy change
The MHRA has updated the guidance for the Innovative Licensing and Access Pathway (ILAP), revising the 'What’s on offer in the ILAP' and 'ILAP application guidance' documents. Key updates were made to the Target Development Profile (TDP) section and the ILAP Joint Scientific Advice (JSA) section. The revisions also include new dates for ILAP application rounds beyond round 5, ensuring continued availability of the pathway for innovative medicines.

Key changes

Revised Target Development Profile (TDP) section; updated Joint Scientific Advice (JSA) requirements; addition of new ILAP application round dates.

Affected workflows

Signal ManagementLabeling

Responsible groups

Regulatory AffairsClinical SafetyPV Operations

PV impact

Sponsors in the ILAP must update their Target Development Profiles to reflect the refined roadmap for regulatory and safety milestones. This requires early coordination between pharmacovigilance and development teams to ensure that scientific advice and safety planning are integrated into the accelerated access pathway.

View regulator source

Source document details

Exact policy details

ILAP Opening
Open for Innovation Passport applications
Applies to: All developers of potentially transformative medicines or drug-device combinations
The ILAP is now open for Innovation Passport applications... (source page 1) · p. 1 · High · Source
Innovation Passport Eligibility Criteria
Must meet all ILAP selection criteria to be awarded an Innovation Passport
Applies to: Developers applying for ILAP
The developer will then proceed to work... (source page 1) · p. 1 · High · Source
TDP Roadmap Updates
Expected to be a living document updated along development timelines
Applies to: All accepted ILAP applications
We expect the TDP roadmap to be a living document... (source page 1) · p. 1 · High · Source
Data Retention Policy
Information held for 10 years
Applies to: All personal and sensitive/confidential information submitted
All information submitted through the ILAP registration portal will be held by the MHRA for 10 years. (source page 4) · p. 4 · High · Source
Personal Data Processing Basis
Consent as legal basis for processing personal data under UK GDPR
Applies to: Individuals applying for the Innovation Passport
We rely on UK GDPR Article 6(1)(a) as our legal basis for processing your personal data. (source page 1) · p. 1 · High · Source

Workflow rule impacts

Country ComplianceMHRA

Streamlined interactions with UK regulatory and HTA systems

New eligibility criteria and collaborative access process under ILAP

By engaging with medicine developers from early stages... (source page 1) · p. 1 · High · Source

Extracted documents

Evidence and confidence

Confidence: highSource updated: Aug 5, 2026

Full briefing

Practical implication

Sponsors in the ILAP must update their Target Development Profiles to reflect the revised TDP and coordinate closely with pharmacovigilance teams for alignment with the new roadmap.

The latest updates to the ILAP guidance include changes to the Target Development Profile and Joint Scientific Advice sections, as well as new application round dates. Sponsors must now ensure their Target Development Profiles align with the newly refined roadmap for regulatory milestones, necessitating early coordination between teams.

What changed: Guidance on the Target Development Profile (TDP) and Joint Scientific Advice (JSA) sections of the ILAP has been revised, with new application round dates provided for subsequent rounds.

Why it matters: These changes require sponsors to adapt their development strategies accordingly, ensuring that safety and scientific advice are integrated into the accelerated access pathway, thereby potentially reducing time to market for transformative therapies.

Practical implication: Sponsors in the ILAP must update their Target Development Profiles to reflect the revised TDP and coordinate closely with pharmacovigilance teams for alignment with the new roadmap.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Labeling#Signal Management#Medicines and Healthcare products Regulatory Agency (MHRA)#revised#policy-change#Guidance#firecrawl-policy-agent

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