DDReg Pharma

Pharmacovigilance Services in Australia

Australia
Reporting adverse drug reactions (ADRs) to the responsible authorities is directly proportional to patient safety. In Australia, the Therapeutic Goods Administration (TGA) oversees reporting of ADR related to medicines and medical devices. Anyone including the public, general practitioners, nurses, other health professionals and the therapeutic goods industry can report ADRs either online through the Australian Adverse Drug Reactions Reporting System or via telephone, post, fax, and email. Whether or not the ADR is confirmed, the TGA assess the causality of that suspected ADR. It is voluntary for the clinicians and the public to report the ADR; however, it is mandatory for the sponsors of both registered and listed drugs to report all the suspected ADRs to the TGA. The main areas of interest for TGA include adverse events related to newly listed or registered drugs, medicine or vaccine interactions, the suspected adverse event not listed in product information or in medical resources, and adverse events leading to death, admission to hospital, prolonged hospitalization, or birth defects. Australia has two databases of adverse event notifications (DAEN) namely, DAEN-medicines and DAEN-medical devices. DAEN-medicines provide information on the adverse events related to medicines and vaccines and DAEN-medical devices provide information on the adverse events related to medical devices used in Australia. One of the challenges that TGA may face is underreporting of the side-effects and non-availability of the comorbidities data, thus limiting the contributory and confounding factors to an adverse event.
As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio for Australia, we provide end-to-end pharmacovigilance services that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.
DDReg Pharmacovigilance Services portfolio include:
ICSR Processing and Submission
Risk Management Plan
Aggregate Reports
Signal Management
QPPV Services
PV Audit & Compliance
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