On November 12, 2012 Australia‘s drug regulator the TGA began recruiting members for the newly established Advisory Committee on the Safety of Vaccines (ACOSV) as regulated “under Part 6 Division 1EB of the Therapeutic Goods Regulations 1990 (the regulations)” the purpose of this body is to “advise and make recommendations to the Minister for Health and the Therapeutic Goods Administration (TGA) on the safety, risk assessment and risk management of vaccines.”
- The committees inaugural meeting was held on March 13, 2013
- TGA has international harmonisation arms
- In Feb 2012 the WHO set a Blueprint for WHO Global Vaccine Safety Initiative
ACSOV handled vaccine safety and risk assessment only and all other “pre-market functions for vaccines” was handled by the Advisory Committee on Prescription Medicines (ACPM).
On January 1, 2017 as part of Government’s October 2016 [5] statutory structural changes, ACSOV and ACPM’s vaccine regulatory roles were consolidated [1] to form TGA’s Advisory Committee on Vaccines (ACV). ACV now “provides independent medical and scientific advice…on issues relating to the safety, quality and efficacy of vaccines supplied in Australia including issues relating to pre-market assessment, post-market monitoring and safe use in national immunisation programs.” [2, 3, 4]
ACV’s role as a statutory advisory committee established by the Therapeutic Goods Regulations 1990, is to hold regular meetings to assess commercial-in-confidence sponsor information in regard to Submissions for Registration, Pharmacovigilance and Immunisation Programs, and provide independent expert scientific and technical advice aid the TGA delegate in making regulatory decisions. ALL advisory decisions now made by one centralised committee!
The ACV was first chaired by Prof. Allen Cheng, with 9 other members. Cheng held additional gate-keeper-like “independent”, highly influential head positions on ATAGI and AusVaxSafety through 2020.