In the UK, Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion. It is the competent authority for clinical trial authorisation for all medicinal products (including ATMPs) and for UK manufacturers or importers of ATMPs.
The Innovative Licensing and Access Pathway (ILAP) is a new pathway launched following Brexit. By providing enhanced regulatory and other expert input, this pathway aims to support innovative approaches to the safe, and timely development of medicines. It is open to both commercial and non-commercial developers of medicines (UK-based and global). It comprises of an Innovation Passport designation, a Target Development Profile (TDP) and provides applicants with access to a TDP toolkit to support all stages of the design, development and approvals process.
A press release can be found here.
