Spring Intro 2023

06/03/2023

All major agencies recognise the need to speed up the approval of drugs that improve clinical care

Speeding the availability of drugs that treat serious diseases are in everyone's interest, especially when the drugs are the first available treatment or if the drug has advantages over existing treatments • Priority Review • Breakthrough Therapy • Accelerated Approval • Fast Track • Project Orbis

Applications may be eligible for accelerated assessment if

An accelerated assessment procedure to prioritise access to new medicines that will benefit patients

the CHMP decides the product is of major interest for public health and therapeutic innovation • PRIority MEdicine (PRIME) • Conditional Approval • Accelerated assessment

• Innovative Licensing and Access Pathway (ILAP) • Rolling Review • Accelerated assessment • Project Orbis

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Similarities and Differences between PRIME scheme and the ILAP pathway.

PRIME

ILAP

Open to novel therapies AND new indications of existing therapies. Support from the MHRA and multiple collaborating stakeholders, including the UK’s Health Technology Authority NICE. Includes the Target Development Profile (TDP) incorporating several different tools that you can add to help you build your product development programme.

Open to new and novel therapies.

Support from experts within the European Medicines Agency (EMA).

Provides guidance on your product development.

Rapporteur and co-rapporteur designation will include experts from different countries within the EU with expertise in country specific regulation. Historically a difficult scheme to be approved for (approximately a 25% approval rate). Fee waivers and reductions for SMEs and academia. PRIME granted at Day 40. Kick-off meeting approximately 3 months later.

The pathway is exclusive to the UK.

Greater than 50 % acceptance rate onto the pathway. No additional fee incentives specific to the ILAP pathway. 4-6 weeks to be granted an ILAP passport, followed by 4-6 weeks to receive your TDP.

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