Europe – Euro Roundup

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the Innovative Licensing and Access Pathway (ILAP) it is setting up to accelerate time to market. Drug developers that follow the pathway will benefit from more input from MHRA and stakeholders including the National Institute for Health and Care Excellence.

Drug developers can access the pathway as soon as they have nonclinical data on a new chemical entity, biological medicine, new indication or repurposed molecule, although the scheme also permits entry once a candidate is somewhat closer to market. MHRA is encouraging companies to apply early in development to maximize the benefits. The pathway is “generally not suitable” for candidates that “are towards the end” of development, MHRA said…