The functions of ACSOV were consolidated into the Advisory Committee on Vaccines on 1 January 2017.The Medicines Safety Update was published five times during 2016. The TGA applies a risk management approach to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy.The TGA uses this three-month period to investigate any potential safety concerns identified.The DAEN, which was launched in 2012, was created to support better health outcomes by providing access to the information that the TGA gathers while monitoring medicine and vaccine safety in Australia.Australian Statistics on Medicines is produced by the Drug Utilisation Sub-Committee of the Pharmaceutical Benefits Advisory Committee and is aimed at providing comprehensive and valid statistics on the Australian use of medicines and vaccines in the public domain to allow access by all interested parties.This report from the PSAB includes a brief overview on the following aspects of post-market monitoring of medicines and vaccines in Australia: The TGA's reporting system for adverse events began in the late 1960s with the computerised database dating back to the early 1970s.ACSOM also provides advice to the TGA on other matters related to pharmacovigilance, including the detection, assessment, understanding and prevention of adverse events.
The number of reports made by sponsors increased from 2012 (8211) to its highest point in 2013 (9563), before dropping back to a similar level in 2014 (8359).
By the end of 2016 there were approximately 329,000 reports of suspected adverse events in the database.
Figure 1: Origin of medicine and vaccine adverse events received by the TGA (2012-16) In 2016 the TGA received approximately 17,000 reports of adverse events.
RMPs accompany applications for registration of high risk medicines, such as new chemical entities.
RMPs characterise and pro-actively manage risks relating to a medicine over its entire life cycle.