This is a preview of subscription content, log in via an institution to check access.
Notes
TGA = Therapeutic Goods Administration
CIOMS = Council for International Organizations of Medical Sciences
E2B is the international standard for transmitting medicine adverse event reports specified by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Reference
Therapeutic Goods Administration. Changes to submission of ADR reports for unapproved medicines and biologicals. Internet Document : 7 Apr 2017. Available from: URL: https://www.tga.gov.au/changes-submission-adr-reports-unapproved-medicines-and-biologicals
Rights and permissions
About this article
Cite this article
ADRs related to unapproved clinical products: TGA changes. Reactions Weekly 1648, 1 (2017). https://doi.org/10.1007/s40278-017-28980-5
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40278-017-28980-5