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Glossary

Innovative Licensing and Access Pathway (ILAP)

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The MHRA’s Innovative Licensing and Access Pathway (ILAP) aims to accelerate the time to market, facilitating patient access to medicines. These medicines include new chemical entities, biological medicines, new indications, and repurposed medicines. 

Horizon scanning and regulatory science will make sure the pathway is at the forefront of innovative developments and has the framework to develop evidence-based practice as modern technologies and methods emerge. 

The ILAP is open to both commercial and non-commercial developers of medicines (UK based and or global). It comprises of an Innovation Passport designation, a Target Development Profile (TDP) and provides applicants with access to a toolkit to support all stages of the design, development, and approvals process. 

The ILAP provides opportunities for enhanced regulatory and other stakeholder input. 

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R

Risk-benefit balance

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P

PMCF study

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