SMC to support innovative new medicines pathway

Experts from the Scottish Medicines Consortium (SMC) are to support a new licensing and access pathway which aims to reduce the time to market for innovative new medicines, allowing patients to benefit from them more quickly.

The Innovative Licensing and Access Pathway (ILAP), which has been developed by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), allows for enhanced coordination and monitoring of product development activities by harnessing expertise from the MHRA, SMC, the National Institute for Health and Care Excellence (NICE) and NHS England and NHS Improvement (NHSE&I).

SMC and NICE will work with the MHRA to consider if a product meets the criteria to be designated as an innovative medicine and be granted an “innovation passport”. The “passport” acts as the gateway to the creation of a “Target Development Profile” that sets out a unique, product-specific roadmap towards patient access for a medicine in the UK healthcare system. SMC and NICE will also act as delivery partners for several tools available to support the Target Development Profile. This collaborative framework will allow the impacts of licensing routes on health technology assessment and commissioning to be considered prospectively to accelerate patient access. The ILAP also provides opportunities for enhanced regulatory and other stakeholder input, including engagement with patients.

The new pathway, which incorporates broad and inclusive concepts of innovation and patient need, will cover Advanced Therapy Medicinal Products (ATMPs), medicines for rare diseases and repurposed medicines.

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