Primary source: ILAP application guidance
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.
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.
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.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Revised Target Development Profile (TDP) section; updated Joint Scientific Advice (JSA) requirements; addition of new ILAP application round dates.
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.
Streamlined interactions with UK regulatory and HTA systems
New eligibility criteria and collaborative access process under ILAP
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.
Published from the Firecrawl policy change extraction pipeline.
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