Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2018 Apr;41(2):50-53.
doi: 10.18773/austprescr.2018.010. Epub 2018 Apr 3.

Pharmacovigilance and expedited drug approvals

Matthew Linger  1 , Jennifer Martin  2
Affiliations
Review

Pharmacovigilance and expedited drug approvals

Matthew Linger et al. Aust Prescr. 2018 Apr.
No abstract available

Keywords: Therapeutic Goods Administration; adverse effects; drug regulation; postmarket surveillance.

PubMed Disclaimer

Conflict of interest statement

Jennifer Martin has contributed to the Therapeutic Goods Administration consultation processes as an employee of the University of Newcastle and as a member of the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists.

Comment in

  • Automated adverse drug reaction detection.
    Keith C. Keith C. Aust Prescr. 2018 Oct;41(5):138. doi: 10.18773/austprescr.2018.049. Epub 2018 Oct 1. Aust Prescr. 2018. PMID: 30410207 Free PMC article. No abstract available.

References

    1. World Health Organization. Essential medicines and health products. Pharmacovigilance. www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/ [cited 2018 Mar 1]
    1. Mackay K. Showing the blue card: reporting adverse reactions. Aust Prescr 2005;28:140-2. 10.18773/austprescr.2005.107 - DOI
    1. Therapeutic Goods Administration. Reporting problems. www.tga.gov.au/reporting-problems [cited 2018 Mar 1]
    1. Therapeutic Goods Administration. Medicines and vaccines post-market vigilance - statistics for 2015. Version 1.0, Nov 2016. Canberra: Department of Health; 2016. www.tga.gov.au/medicines-and-vaccines-post-market-vigilance-statistics-2015 [cited 2018 Mar 1]
    1. Moore TJ, Furberg CD, Mattison DR, Cohen MR. Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014. Pharmacoepidemiol Drug Saf 2016;25:713-8. 10.1002/pds.3979 - DOI - PubMed

LinkOut - more resources