MHRA unveils ‘innovation passport’ for new medicines
A licensing pathway that will reduce the time it takes for novel medicines to enter the marketplace has been launched by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
According to the agency’s announcement on January 4, the Innovative Licensing and Access Pathway (ILAP), provides a “single integrated platform for sustained and collaborative working between the MHRA, its partners and the medicine developer”.
According to the statement, the pathway will usher in “a new era” in medicines approvals in the UK and support the safe, timely and efficient development of innovative products. Medicines covered by the ILAP will include new chemical entities, biological medicines and repurposed medicines.
To access the pathway, companies in the life sciences sector will have to submit their product to the ILAP so it can be determined if it qualifies for an “innovation passport”.
This passport step assesses the product based on its level of innovation alongside patient need. Designed to fast-track a wide range of medicines undergoing development, the pathway will prioritise advanced therapy medicinal products, medicines for rare diseases and repurposed medicines.
If the applicant is successful in obtaining an “innovation passport”, the company will gain a “target development profile” (TDP). The TDP includes access to tools that can design an efficient and “regulation and access ready” development programme. Available tools will include a continuous benefit-risk assessment, increased support for novel development approaches and enhanced patient engagement.
Lord Bethell, UK Minister for Innovation, said: “We are absolutely determined to make sure UK patients can access the latest cutting-edge medicines as quickly as possible to help everybody live longer, healthier and happier lives.”
He added that as the UK had now left the EU, the MHRA had more freedom to innovate and cut red tape to speed up the approval process for new treatments and ensure patient safety.
“The new pathway represents a totally new way of thinking and is a truly collaborative approach between the healthcare system, the pharmaceutical industry and patients with the common goal of getting the best products to the people who need them as safely and quickly as possible,” he added.
June Raine, chief executive, MHRA said: “We are transforming the MHRA, making the regulator an enabler of innovation. Our new ILAP has established new partnerships to robustly and safely support all new medicines at any point in their development, and most important of all, involve patients in all aspects of decision-making.”
Gillian Leng, chief executive of the National Institute for Health and Care Excellence (NICE), also welcomed the development. “Partnering with the MHRA and others to build this frictionless pathway to the timely availability of cost-effective medicines is one of the ways NICE is delivering benefits for patients, the NHS, and life sciences industry,” she said.
To find out further information about the ILAP and how to apply for an innovation passport, visit here.
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