UK rolls out new drug approval pathway

Effective 1 January 2022 Pharmaceutical companies can now seek accelerated drug approvals in the UK using the newly launched Innovative Licensing and Access Pathway (ILAP). The new approval pathway marks a collaboration by multiple UK government entities, including the National Institute for Health and Care Excellence, the Medicines and Healthcare products Regulatory Agency (MHRA), the Scottish Medicines Consortium and the National Health Service.

Under the new pathway, government officials will advise sponsors who plan to sell their products in the UK, to help speed the process from clinical trials to patients receiving treatment. According to the MHRA, drug developers can use the 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 said it is “generally not suitable” for drugs near the end of development.