- Title
- Pharmacovigilance and expedited drug approvals
- Creator
- Linger, Matthew; Martin, Jennifer
- Relation
- Australian Prescriber Vol. 41, Issue 2, p. 50-53
- Publisher Link
- http://dx.doi.org/10.18773/austprescr.2018.010
- Publisher
- National Prescribing Service
- Resource Type
- journal article
- Date
- 2018
- Description
- Pharmacovigilance is the detection and assessment of adverse events related to any drug used in clinical practice. In Australia adverse events can be reported to the Therapeutic Goods Administration. Reports are encouraged, even if the drug is old or the prescriber is only suspicious of an adverse event. Australian information about adverse events can be found online in the Database of Adverse Event Notifications and in the publication Medicine Safety Update. The Therapeutic Goods Administration is currently exploring expedited approval pathways to enable some drugs to reach the market quickly. As there will be limited clinical data about these drugs, postmarketing pharmacovigilance will be of increased importance.
- Subject
- adverse effects; drug regulation; postmarket surveillance; Therapeutic Goods Administration; SDG 3; Sustainable Development Goals
- Identifier
- http://hdl.handle.net/1959.13/1465110
- Identifier
- uon:47209
- Identifier
- ISSN:0312-8008
- Rights
- © 2018 NPS MedicineWise. Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) https://creativecommons.org/licenses/by-nc-nd/4.0/.
- Language
- eng
- Full Text
- Reviewed
- Hits: 681
- Visitors: 864
- Downloads: 187
Collections
Goal 3: Good Health and Well-Being
| Thumbnail | File | Description | Size | Format | |||
|---|---|---|---|---|---|---|---|
| View Details Download | ATTACHMENT02 | Publisher version (open access) | 120 KB | Adobe Acrobat PDF | View Details Download |