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Presentation: Revision of the Uniform Recall Procedure for Therapeutic Goods (URPTG)

TGA presentations: ARCS Scientific Congress Canberra, 10-11 August 2016

15 August 2016


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The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.


  • Presented by: Joshan Joy
  • Presented at: ARCS Scientific Congress Canberra
  • Presentation date: 10-11 August 2016
  • Presentation summary: This presentation discusses the revision of the Uniform Recall Procedure for Therapeutic Goods including the major changes from the 2014 version.


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

Slide 1 - The URPTG

(current) 2004 edition

Available online at Uniform recall procedure for therapeutic goods (URPTG), 2004 edition

Slide 2 - 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

Slide 3 - 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

Slide 4 - 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

Slide 5 - 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

Slide 6 - Recall Classification - changes

  • Class I
    • 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 II
    • 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 III
    • a situation in which use of, or exposure to, the deficient product is not likely to cause adverse health consequences

Slide 7 - Process for biologicals and other immediate actions

The flow chart for Process for biologicals and other immediate actions is described below as a series of bullet points and numbered steps. - Immediate and significant threat. Go to step 1. - Actual (or potential) product tampering. Go to step 1. - Human blood or a blood component. Go to step 1. - Biologicals. Go to step 3. - Radiopharmaceuticals. Go to step 3. 1) Contact the Australian Recall Co-ordinato. Go to step 2 or 3. 2) Implement and report on the agreed recall strategy. Finish 3) Contact customers. Go to step 1 or 2.

Slide 8 - 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

Slide 9 - 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

Slide 10 - 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

Slide 11 - 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

Slide 12 - 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

Slide 13 - 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

Slide 14 - 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

Slide 15 - Number of recall actions

A line graph displaying the number of recall actions for Medicines, Medical devices (including IVDs), Biologicals, and Blood. Displayed in 6 month increments from July 2014 to June 2016.

Slide 16 - Recalls vs ARTG entries - devices and medicines

A line graph displaying the Recall Ratio for devices on one line and the Recall Ratio for Medicines on another.

Slide 17 - 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

Slide 18 - Main reasons for medicine recalls

  • Mechanical and physical defects
  • Software defects
  • Labelling and packaging
  • Diagnostic inaccuracy
  • Electrical defects
  • Sterility issues
  • Adverse events

Slide 19 - Questions

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