FOI disclosure log

Special Access Scheme data for Oritavancin for the period 
1 January 2018 to 31 October 2024.

• FOI 25-0080 (pdf,83.3KB)

Documents in the possession of the office of the Deputy Secretary and/or the Chief Medical Advisor since 1 January 2024 that relate to the causes - known, suspected or speculated - of shortages of intravenous fluid products in Australia.

Please note that the documents represent a point in time early on in the shortage. Refer to the TGA website for the most up to date information on medicine shortages.

• FOI 5350 (pdf,1.17MB)

Documents relating to the haemoperfusion device manufactured by Foshun Biosun Medical Technology Co. Ltd (Biosun)

• FOI 25-0001 (pdf,303.06KB)

List of unregistered medicinal cannabis products supplied for the period 1 January 2024 to 30 June 2024.

• FOI 25-0043 (pdf,148KB)

Summary of all payments received from Pfizer, AstraZeneca, and Moderna from 1 July 2019 to 1 July 2024

• FOI 5348 (XLSX,8.61MB)

Two spreadsheets generated outlining adverse event reports (AERs) in the Adverse Event Management System (AEMS) for the following:

1. Adverse event report data for the time between the most recent non-covid vaccination and death, for the timeframe of 1 January 2004 to 5 September 2024 for accepted cases.
2. Adverse event report data for the time between the most recent covid-19 vaccination and death for the timeframe of 1 December 2020 to 5 September 2024 for accepted cases.

• FOI 25-0047 (XLSX,20.44KB)

Documents relating to the Advisory Committee on Medicines Minutes of meeting 44 (Section B Post-market items Sodium Valproate), including ratified minutes, presentation slides and agenda pack.

• FOI 5351 (pdf,6.77MB)

Copies of Good Manufacturing Practices (GMP) audit checklists, used for listed medicines manufacture.

• FOI 25-0045 (pdf,69.75KB)

Request for the 30 most recent FOI charges notices. Any subsequent decisions regarding contentions over charges and decisions on Internal Review or Information Commissioner reviews of charges.

• FOI 25-0037 (pdf,2.88MB)

Request for first document that suggests there may be an internal signal detection showing there may be a correlation between MRNA vaccine and death in the elderly.

• FOI 25-0033 (pdf,49.45KB)

Approvals given by the TGA to use Sodium Thiosulfate under the Special Access Scheme (SAS) and Authorised Prescriber Scheme (APS).

• FOI 25-0002 (pdf,106.28KB)

Special Access Scheme data for multiple scan products for the period
1 January 2021 to 17 September 2024.

• FOI 25-0025 (pdf,5.61MB)

Request for documents relating to TGA's approval and pharmacovigilance for Gardasil 4 (2007-2015).

• FOI 5276 (pdf,3.74MB)

Special Access Scheme Category A, B and C data sets for triclabendazole, ibrexafungerp, flucytosine, diethylcarbamazine, levofloxacin and fumagillin.

• FOI 25-0029 (XLSX,311KB)

Product Information and Consumer Medicine Information documents for Capecitabine-DRLA (Capecitabine) Tablets as at 14 September 2020.

• FOI 25-0034 (pdf,971.79KB)

Documents relating to evidence for the efficacy of Caruso’s ‘Prostate EZE Max.’

• FOI 3121 (pdf,12.7MB)

Approval documents relating to Wegovy, including the Delegate's Overview, Clinical Evaluation report and Non-Clinical Evaluation report.

• FOI 5280 (pdf,1.36MB)

Documents relating to laboratory testing of Spikevax vaccines.

• FOI 5199 (pdf,3.4MB)

Evidence of website edits related to SAS procedures.

• FOI 5202 (pdf, 18.3MB)

Eleven ARTG summary printouts for cancelled breast implant products.

• FOI 25-0008 (pdf,831.25KB)

Data of unregistered medicinal cannabis products supplied for the period 1 January 2024 to 30 June 2024, taken from the six-monthly reports submitted by product sponsors.

• FOI 25-0003 (pdf,236KB)

COVID-19: Request for a list of DAEN notifications of the 1004 deaths notified "COVID vaccine safety report 2/11/23".

• Document 1 (XLSX,22.55KB)

Three spreadsheets generated outlining adverse event reports (AERs) in the Adverse Event Management System (AEMS) for the following:

1. Case number and age for adverse events with a fatal outcome that involve a non-covid vaccine, for the timeframe of 1 January 2004 to 14 August 2024 including both accepted and rejected cases.
2. Adverse event report data for the time between the most recent non-covid vaccination and death, for the timeframe of 1 January 2004 to 14 August 2024 including both accepted and rejected cases.
3. Adverse event report data for the time between the most recent covid-19 vaccination and death for the timeframe of 1 December 2020 to 14 August 2024 including both accepted and rejected cases.

• Document 1 (XLSX,15.28KB)
• Document 2 (XLSX,12.22KB)
• Document 3 (XLSX,18.95KB)

Two spreadsheets generated outlining case numbers and age (years) for all adverse event reports in AEMS database for non-covid and covid vaccines between 1 Jan 2004 to 6 Sep 2024.

• Document 1 (XLSX,10.31MB)
• Document 2 (XLSX,3.29MB)

Protocol for assessing the presence of residual DNA in the mRNA COVID-19 vaccine products provisionally approved by the TGA.

• FOI 5286 (pdf, 747KB)

Documents relating to TGA reference number ARTG 225818 Safe Obstetrics Systems foetal membrane

• FOI 5179 (pdf,2.74MB)

Special Access Scheme and Authorised Prescriber data for ‘Glycopyrrolate’ from 1 January 2023 to 1 March 2024

• Document 1 (XLSX,32KB).
• Document 2 (XLSX,15KB). 

Summary of charges for the last 30 finalised FOI requests

• FOI 5347 (pdf,101KB)

Documents relating to the registration of certain generic drugs

• FOI 4957 (pdf,524KB)

List of all import referrals to TGA received from Australian Border Force regarding Semaglutide

• FOI 5321 (pdf,22KB).

Special Access Scheme and Authorised Prescriber data for Dalbavancin for the period 1 January 2021 to 30 June 2024.

• FOI 5317 (pdf,111KB)

Documents related to the risk of kidney injury/disease or gastric cancer as a result of the usage of proton pump inhibitors 

• FOI 5169 (pdf,2.74MB)

COVID-19 Adverse Event Reports and List of Serious Cases

• FOI 5293 - Document 1 (XLSX,231KB)
• FOI 5293 - Document 2 (XLSX,2,857KB)

COVID-19:  Document detailing generalised information on the authors of relevant supporting documents that informed the AusPAR for Comirnaty BNT162b2.

• Document 1 (pdf,111KB). 

Special Access Scheme Category A and B applications granted for unregistered antimicrobials from January 2017 to December 2023

• FOI 5308 (XLSX,1.11MB)

Delegate’s Overview for Lexapro

• FOI 5171 (pdf,3.53MB)

Authorised prescriber approvals for Psilocybin and MDMA from 1 July 2023 to 30 June 2024

• FOI 5316 (pdf,75.22KB)

Non-clinical evaluation report for pregabalin in Lyrica

• FOI 5049 (pdf,13.18MB)

Emails and notifications received by the TGA containing "Relx", "QuitRX" and "Quitmed"

• FOI 5107 (pdf,19.43MB)

Data relating to Authorised Prescriber and Special Access Scheme pathways for medicinal cannabis

• FOI 5255 - Document 1 (pdf,1.25MB)
• FOI 5255 - Document 2 (XLSX,1.13MB)
• FOI 5255 - Document 3 (XLSX, 423KB)
• FOI 5255 - Document 4 (XLSX, 2.84MB)
• FOI 5255 - Document 5 (XLSX, 5.24MB)
• FOI 5255 - Document 6 (XLSX, 7.21MB)
• FOI 5255 - Document 7 (XLSX, 22.6MB)
• FOI 5255 - Document 8 (XLSX, 7.46MB)
• FOI 5255 - Document 9 (XLSX, 7.81MB)
• FOI 5255 - Document 10 (XLSX, 6.69MB)
• FOI 5255 - Document 11 (XLSX, 7.99MB)
• FOI 5255 - Document 12 (XLSX, 2.68MB)
• FOI 5255 - Document 13 (XLSX, 28.3KB)
• FOI 5255 - Document 14 (XLSX, 368KB)

Documents relating to SPL7013, Astodrimer, Viraleze and Starpharma

• FOI 5023 - Document 32 (pdf,215KB)

List of all new chemical and biological entities approved by the TGA

• FOI 5224 (pdf,173.36KB)

Safety Study Test for the approval and registration of the first Gardasil vaccine.

• FOI 1890 (pdf,13.85MB)

Briefing documents prepared by the TGA for the Minister for Health and Aged Care regarding safety issues associated with antidepressants, antipsychotics, benzodiazepines and z-drugs

• FOI 5170 (pdf,217.04KB)

Documents relating to COVID-19 vaccine safety signal investigation processes

Please note: Product Information (PI) documents, published on the TGA website, are the most up-to-date reference for adverse events associated with individual COVID-19 vaccines products. The following document may refer to statistical signals that were not confirmed for further review, that were not found to be clinically meaningful, or that were unable to be validated with population-evidence sufficient to confirm an association. Internal TGA Standard Operating Procedures (SOP) and Work Instructions (WI) are designed for use by persons who have undertaken formal TGA induction and on-the-job training. It would be inappropriate for these documents to be utilised as written by someone who is not orientated to the science of pharmacovigilance and the work of the organisation.

• FOI 5082 (pdf,13.2MB)

Consumer Medicine Information (CMI) and Product Information (PI) documents for Loxalate, Lexapro, Chemmart Brand Escitalopram, Escitalopram

• FOI 5137 (pdf,1.20MB)

Documents relating to the assessment and approval of Nirsevimab (Beyfortus)

• FOI 5046 (pdf,8.91MB)

Special Access Scheme and Authorised Prescriber data for [18F]Fluorodeoxyglucose (FDG) PET scans performed for brain cancer for the period 1 January 2018 to 1 June 2024

• FOI 5201 (pdf,294.33KB)

Confirmation of cancellation and date of cancellation for Natrelle Saline-Filled Breast Implants, including styles SRL, SRF, SRM and SRX and Natrelle Silicone-Filled Textured Breast Implants, including styles SRL, SRF, SRM and SRX

• FOI 5192 (pdf,141.64KB)

COVID-19: Adverse event data with time to onset included and concomitant medicine information excluded. 

• FOI 5205 (pdf,128KB)