This presentation discusses the revision of the Uniform Recall Procedure for Therapeutic Goods including the major changes from the 2014 version.

1. Revision of the Uniform Recall Procedure
for Therapeutic Goods (URPTG)
Joshan Joy
Acting Director, Recalls and Case Management Section
Manufacturing Quality Branch
Medical Devices and Product Quality Division, TGA
ARCS Scientific Congress Canberra 2016
10 - 11 August 2016

2. The URPTG
(current) 2004 edition
Available online at
https://www.tga.gov.au/publication
/uniform-recall-procedure-
therapeutic-goods-urptg-2004-
edition-0
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3. Stakeholder engagement
• Feedback gained from dealing with individual actions over
the years
• Targeted consultation in April 2015 through release of a
discussion paper
• Released the draft URPTG for public consultation in October 2015
• Presentation in TGA – Industry Forums regarding the changes
• Publication of the response to the consultation feedback with the
revised URPTG
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4. Revised URPTG – major changes
• Web based format – easy to navigate
• Step-by-step protocol with supporting information
• New/changes to recall terminologies
• Risk classification – inclusion of probability aspects
• Process for biologicals recall actions
• Greater clarification on the requirements for medical devices
(including IVDs)
• Refined information required to assess recall actions
• Publication of recall actions
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5. Structure - revised URPTG
• Overview
• Recall procedure
• Recalls and non-recall actions
• Sponsor’s customer letter
• Advertisements: Consumer level recalls
• Roles in recalling TGs
• Mandatory recalls
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6. Recall actions – changes
The proposal is to have four types of recall actions:
• Recall – the permanent removal of deficient goods from the market or from use
• Recall for Product Defect Correction – repair, modification, adjustment, re-labelling,
update to instructions or labelling
• Hazard Alert – providing information to health practitioners regarding the issues to
implantable medical devices and advice on how to manage such patients
• Product Defect Alert (new term) – undertaken for critical therapeutic goods for which
there is no alternative product or for which a recall action will result in interruption of patient
treatment or a shortage
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7. Recall Classification – changes
• A situation in which there is a reasonable probability that the use of, or exposure
to, a deficient product will cause serious adverse health consequences or death
Class
I
• A situation in which use of, or exposure to, a deficient product may cause
temporary or medically reversible adverse health consequences or where the
probability of serious adverse health consequences is remote
Class
II
• A situation in which use of, or exposure to, the deficient product is not likely to
cause adverse health consequences
Class
III
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8. Process for biologicals and other immediate actions
Immediate
and significant
threat
Actual (or
potential) product
tampering
Human blood or
a blood
component
Biologicals Radiopharmaceuticals
Contact the
Australian Recall Co-ordinator
Contact Customers
Implement and report on the agreed
recall strategy
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9. Who identifies the issues?
• The manufacturer through the implementation of the QMS/ GMP
processes
• TGA through our post-market monitoring and compliance activities like
lab testing
• Other regulators who notify the TGA through international collaborative
activities
• Regulator inspections of manufacturers
• Third party inspections (e.g. by clients)
• Other avenues
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10. Legislative context
Most recall actions are initiated by the
manufacturer or sponsor, such actions are
required under the therapeutic goods
legislative framework and are not voluntary
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11. Legislative context
• The Therapeutic Goods Act 1989
- s30EA for medicines and other therapeutic goods,
s41KA for medical devices, s32HA for biologicals and
s42V for goods subject to actual or potential tampering
- covers the Secretary’s powers and processes for
mandating recalls not only for TGs in the ARTG, but also
for exempt, cancelled or illegally supplied TGs
• Competition and Consumer Act 2010 (consumer goods)
- notification to ACCC for safety related actions
- consumer guarantees while undertaking recall actions
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12. Responsibilities - Manufacturers
• Has established recall procedures in
place to initiate a recall action
• Has established relationship with the
Australian Sponsor, including the ability
to quickly provide information when requested
• Identifies issues requiring recall or non-recall action
• Risk assessment (also known as HHE/HHA)
• Identifies root cause and implements CAPA
• Have an effective QMS/GMP processes in place
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13. Responsibilities – Sponsors
• Takes primary responsibility for implementing the recall action (but can authorise
third parties)
• Submits proposed communication strategy and draft letters to the TGA
• Submits a risk assessment (HHE/HHA) undertaken by the manufacturer or market
authorisation holder for the issues identified
• Maintains product distribution details (and provides to the TGA) to assist in
facilitating a recall action
• Has established recall procedures in
place to undertake a recall action
• Reporting on the progress of the recall
action
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14. Responsibilities – TGA
• Undertakes independent review of risk
• Reviews recall strategy and correspondence and provides agreement to initiation
of recall action
• Advises stakeholders (primarily the state and territory health departments) of recall
actions including release of distribution details to monitor the effectiveness of the
recall
• Publication of all recalls in the SARA database
• TGA web statements for Hazard Alerts, consumer level and sensitive recall actions
• Reviews root cause and CAPA and closes-out the recall action
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15. Follow-up reporting
The reporting requirements are:
• 2 and 6-week progress reports are required after the commencement of the
recall
• Close-out report requirements (usually 3 months or another agreed
timeframe):
• the results of the recall - quantity of stock returned, outstanding etc
• the means of disposal, destruction or correction to the recalled goods and
confirmation that this has been
carried out
• details of the root cause analysis and
CAPA to prevent the problem from recurring
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16. Number of recall actions
Jul-Dec 14 Jan-Jun 15 Jul-Dec 15 Jan-Jun 16
Medicines 22 23 31 26
Medical devices (including IVDs) 291 286 291 321
Biologicals - - - -
Blood 60 77 95 67
0
50
100
150
200
250
300
350
Count
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17. Recalls vs ARTG entries – devices and medicines
0
0.001
0.002
0.003
0.004
0.005
0.006
0.007
0.008
Jun-Dec 14 Jan-Jun 15 Jul-Dec 15 Jan-Jun 16
Recall Ratio -
Devices
Recall Ratio -
Medicines
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18. Main reasons for medicine recalls
• Manufacturing issues (e.g.: deviation from sterility assurance
procedures)
• Out of specification – stability, impurity etc.
• Contaminants – microbial, foreign materials, particulates etc.
• Labelling/ packaging issues
• Adverse events
• Supply of illegal or undeclared medicine
• Dosing issues due to defect in the delivery system
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19. Main reasons for medical device recalls
• Mechanical and physical defects
• Software defects
• Labelling and packaging
• Diagnostic inaccuracy
• Electrical defects
• Sterility issues
• Adverse events
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20. Questions
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