Alongside its duties in evaluating safety and effectiveness of drugs and their postmarketing monitoring, the U.K. Medicines and Healthcare products Agency (MHRA) has now been handed a further brief to support economic growth.
The University of Oxford and Moderna Inc. have announced authorization by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a phase I/II study of mRNA-4194, Moderna’s investigational mRNA-based cancer vaccine for Lynch syndrome.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on changes it is proposing to the legal definition of gene therapies, to reflect the advances in technology and manufacturing over the two decades since the current legislation was drawn up. The aim is to correct the mismatch between regulatory terminology and modern science, which MHRA says “can lead to uncertainty” over how a product is classified and to “inconsistent oversight and potential barriers for developers."