Australian Adverse Drug Reaction Committee (ADRAC) to be replaced.(Regulatory Action and News)

Australia -- The Australian Adverse Drug Reaction Committee (ADRAC) is to be abolished and a new committee set up to take a more pro-active approach to drug safety and post-marketing surveillance of medicines.

ADRAC will be replaced by a Medicines Safety Committee as part of a 'whole-of-lifecycle' approach to pharmacovigilance for prescription medicines. The new approach will also bring in drug audits, the appointment of an individual 'drug monitor' to oversee safety of specific drugs and a more flexible protocol that will allow drugs to be suspended rather than withdrawn or recalled when safety issues arise.

In the reforms planned for next year, the TGA says …