• 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...
  • EMA Guide on Development of Novel Drug Development Methodologies Released

    The European Medicines Agency (EMA) released a new guidance on 26 January that addresses the development of novel methodologies in drug development, and how EMA develops qualification opinions and advice for scientific methods and protocols. The qualification process is a "new, voluntary scientific pathway leading to either a [Committee for Medicinal Products for Human Use (CHMP)] opinion or a Scientific Advice on innovative methods or drug development tools." The pr...