MHRA Launches Accelerated Drug Development Program
A new accelerated approval program will be available in 2021 to sponsors in the UK under the Medicines and Healthcare products Regulatory Agency’s (MHRA) Innovative Licensing and Access Pathway (ILAP).
According to MHRA, drug developers can use ILAP once they have nonclinical data on a new chemical entity, biological medicine, new indication or repurposed molecule. The agency said candidate drugs that are closer to market can also use the pathway, but warned it is “generally not suitable” for drugs near the end of development.
UK officials say they have created application tools to support ILAP, including an adaptive inspections tool for use in the preclinical and clinical stages of development.
Application forms and copies of the guidance are available here: https://bit.ly/3rLpXoW.