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GCP: A Question & Answer Reference Guide
* For section 5.5.11, records are required to be retained by the sponsor for 15 years following the completion
of a clinical trial (unchanged from (R1));
* For section 5.13, the 'applicable GMP' in Australia refers to 'PIC/S Guide to Good Manufacturing Practice
for Medicinal Products' (//tga.gov.au/publication/manufacturing-principles-medicinal-products) (in particular
Annex 13) and the 'Australian Code of Good Manufacturing Practice for human and blood components, human
tissues and human cellular therapy products' (//tga.gov.au/publications/australian-code-good-manufacturingpractice-human-blood-and-blood-components-human-tissues-and-human-cellular-therapy-products) (new);
* For section 5.17.2, the TGA has adopted the "ICH Guideline for Clinical Safety Data Management: Definitions
and Standards for Expedited Reporting" in principle, particularly its reporting timelines. Trial sponsors should
refer to the guidance published by the NHMRC: 'Safety monitoring and reporting in clinical trials involving
therapeutic goods' ((R1) comment amended).
* Please find the TGA full annotations at //www.tga.gov.au/publication/note-guidance-good-clinical-practice.
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Q. Does the TGA carry out GCP inspections?

A. No, only GMP inspections and as of 2016 starting piloting Pharmacovigilance inspections. However, since
2005, the TGA has indicated the intention to start GCP inspections - which the TGA is authorized to conduct based on the EU directive on GCP inspection capability for member states, starting with voluntary site inspections
of industry sponsored multi-centre trials. [Editor's note: however, for various reasons-staff turn-over/capacities
and/or limited resources in general-the GCP inspection program has not (as of end 2017) been initiated to the
best knowledge of the Editor].
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Q. Have any foreign Health Authorities conducted GCP inspection in Australia, and, if yes, what are the
results from these inspections?

A. Yes, the US FDA (CDER) has conducted twenty-one (23) GCP inspections from 1989 to End 2016 at Australian
investigator sites, none of which resulted in an official action indicated (OAI) classification; no 2017 site inspections
were added to the list (the 'Clinical Investigator Inspection CLIIL', databases last searched March 2018); however,
at least three (3) site inspections were conducted in 2017 [personal communications]. In addition to the CDER
inspections, CBER has conducted seven (7) clinical investigator inspections, three (3) in 1996 and four (4) in 2011
with none classified as OAI. Staff from the TGA has participated in some of the FDA site inspections as observers/
trainees [personal communication].
EMA GCP inspectors have also conducted a limited number of investigator site/sponsor inspections in Australia
according to the EMA report 'Classification and analysis of GCP inspection findings of GCP inspections conducted
at the request of the CHMP (Inspection reports to EMA 2000-2012)' (EMA/GCP/46309/2012, 01 December 2014)
four (4) routine inspections were conducted in Australia from 2000 to 2012 with a total of seven (7) major findings
(no critical) in the categories of 'selection criteria, safeguard of the safety and well-being of subjects, and reporting
in CRF/Diary.' Furthermore, for 2013, three (3) inspections were conducted in Australia according to the 'Annual
report of the GCP Inspectors Working Group 2013' (EMA/INS/GCP/123295/2013, 28 April 2014), however no
specific data is available on the findings; for 2014 according to the 'Annual report of the GCP Inspectors Working
Group 2014' (EMA/INS/GCP/434373/2014, 2 July 2015) two (2) inspections (one routine and one non-routine)
were conducted in Australia/NZ, but it was not specified whether one or both was conducted in Australia; and for
2015 seven (7) routine inspections were conducted in Australia/NZ according to the 'Annual report of the GCP
Inspectors Working Group 2015' (EMA/INS/GCP/137204/2016, 28 July 2016), but again it was not specified in
which of the countries they were conducted; however, at least two of these were conducted in Australia, as the
Editor conducted pre-(EMA)inspection visits at two Australian investigator sites in July 2015. And according to the
EMA report covering inspections in 2017 (EMA/INS/GCP/763873/2016, 15 June 2017) Australia/NZ is included
under the umbrellas 'Middle East/Asia/ Pacific' and 'ROW', respectively, with a total of 50 inspections conducted,
however no breakdowns in individual countries were provided, and this Editor has not received information on any
potential EMA site inspections in 2017.
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Q. Is there a certification programme for Ethics Committees in Australia?

A. Yes, there is a voluntary 'National Certification Scheme of Institutional Processes for Health Research Ethics

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