• MHRA Publishes New Report on Regulation of Medicines

    UK's Medicines and Healthcare products Regulatory Agency (MHRA) released a new report introducing "new, proportionate approaches to regulation of medicines" that aims to keep in place the same standards of safety now in place. The report, released by MHRA 14 March, is the fifth publication in a series of reports filed under the Better Regulation of Medicines Initiative (BROMI). The report "highlights new priority areas of work in the reclassification of medicines a...
  • Paper: Small Companies Need Regulatory Assistance from EMA

    The European Medicines Agency (EMA) needs to assist companies-particularly small businesses, academic institutions and charities-in the development of advanced-therapy medicines, claims a new paper written by members of the Committee for Advanced Therapies (CAT) in the journal Molecular Therapies . These smaller drug development entities often lack the resources necessary to "navigate regulatory procedures," including clinical trials and application submissions. The pa...