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Date Time MHRA Innovative Licensing and Access Pathway is open for business The ambition of this new licensing and access pathway is to reduce the time to market for innovative medicines. The ILAP combines the MHRA’s globally recognised strengths of independence and high standards of quality, safety, and efficacy, with improved efficiency and flexibility, readying the MHRA for a new era in medicines approvals in the UK. Central to realising this ambition is how the ILAP provides a single integrated platform for sustained collaborative working between the MHRA, partners and the medicine deve...

The MHRA Innovative Licensing and Access Pathway is open for business The Medicines and Healthcare products Regulatory Agency (MHRA) today, 1 January 2021, formally starts the Innovative Licensing and Access Pathway (ILAP). From: 1 January 2021 The ambition of this new licensing and access pathway is to reduce the time to market for innovative medicines. The ILAP combines the MHRA’s globally recognised strengths of independence and high standards of quality, safety, and efficacy, with improved efficiency and flexibility, readying the MHRA for a new era in medicines approvals in the U...

Apply for a licence to market a medicine in the UK How to license a medicine for sale in the UK, including applications through national and international routes. From: Contents Print this page This guidance also covers licensing a medicine in Northern Ireland through the centralised, decentralised and mutual recognition European procedures. Which procedure to follow There are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) or Northern Ireland. The options available will be determined by the intended market a...

Source: UK Government The ambition of this new licensing and access pathway is to reduce the time to market for innovative medicines. The ILAP combines the MHRA’s globally recognised strengths of independence and high standards of quality, safety, and efficacy, with improved efficiency and flexibility, readying the MHRA for a new era in medicines approvals in the UK. Central to realising this ambition is how the ILAP provides a single integrated platform for sustained collaborative working between the MHRA, partners and the medicine developer. By harnessing expertise at the right time from ...

Innovative Licensing and Access Pathway (ILAP) for medicines Guidance for applicants on applying to the ILAP From: Details The 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. The ILAP awards a new “innovative medicine” designation (Innovation Passport), utilises tools from a toolkit and a “Road Map” (Target Development Profile, TDP). The pathway brings together innovative approaches to support...