Drug regulation


Drug regulation is the control of drug use by international agreement and/or by regulatory authorities such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Pharmaceutical and Medical Devices Agency (PMDA). This includes regulations concerned with the development, approval, manufacturing and marketing of drugs.

Latest Research and Reviews

News and Comment

  • Comments and Opinion |

    Scientific Advice meetings are a mechanism to improve communications between drug developers and regulators during the drug-development process. While standard practice for industry, the benefits provided by these meetings are under-utilised by academia. In the context of drug repurposing, can scientific advice, as part of a proposed new R&D tax credits scheme, help to unblock some of the obstacles in the way to clinical adoption?

    • Pan Pantziarka
  • Comments and Opinion |

    Precision medicine has dramatically changed the landscape of drug development in oncology, but this paradigm shift remains to be adopted in early phase clinical trials of molecularly targeted agents and immunotherapeutic agents in children with cancer. The authors, members of the Innovative Therapies for Children with Cancer (ITCC) Consortium, describe trial design strategies to enable drugs with promising activity to progress rapidly to randomized studies and, therefore, substantially accelerate drug development for children and adolescents with cancer.

    • Lucas Moreno
    • , Andrew D. J. Pearson
    • , Xavier Paoletti
    • , Irene Jimenez
    • , Birgit Geoerger
    • , Pamela R. Kearns
    • , C. Michel Zwaan
    • , Francois Doz
    • , Andre Baruchel
    • , Josef Vormoor
    • , Michela Casanova
    • , Stefan M. Pfister
    • , Bruce Morland
    • , Gilles Vassal
    •  & on behalf of the Innovative Therapies for Children with Cancer (ITCC) Consortium
  • Comments and Opinion |

    New opportunities to develop innovative — and often complex — products that combine drugs, devices and/or biological components are rapidly emerging, raising questions about how such products should be regulated. Here, we discuss the ongoing efforts of the FDA to develop a modern, transparent, flexible and consistent science-based regulatory approach for combination products.

    • Nina L. Hunter
    •  & Rachel E. Sherman
  • Comments and Opinion |

    Few biomarkers progress from discovery to become validated tools or diagnostics. To bridge this gap, three European biomedical research infrastructures — EATRIS-ERIC (focused on translational medicine), BBMRI-ERIC (focused on biobanking) and ELIXIR (focused on data sharing) — are paving the way to developing and sharing best practices for biomarker validation.

    • Alain J. van Gool
    • , Florence Bietrix
    • , Eric Caldenhoven
    • , Kurt Zatloukal
    • , Andreas Scherer
    • , Jan-Eric Litton
    • , Gerrit Meijer
    • , Niklas Blomberg
    • , Andy Smith
    • , Barend Mons
    • , Jaap Heringa
    • , Wim-Jan Koot
    • , Martin J. Smit
    • , Marian Hajduch
    • , Ton Rijnders
    •  & Anton Ussi