Recall of Therapeutic Goods - Overview 2018 GMP Forum Craig Davies - - PowerPoint PPT Presentation

Recall of Therapeutic Goods - Overview

2018 GMP Forum

Craig Davies Australian Recall Coordinator and Director - Recalls Section Manufacturing Quality Branch

26 June 2018

Recalls section’s functions

For all therapeutic goods:

• Coordinate recall actions – a Department of

Health mission critical activity

• Coordinate non-recall actions
• Address product tampering issues
• Review notifications from overseas regulators
• Monitor emerging product issues

Uniform Recall Procedure for Therapeutic Goods (URPTG)

A recall is a market action taken to resolve a problem with a therapeutic good for which there are deficiencies or potential deficiencies in:

– Safety – Quality – Performance (medical devices) – Efficacy (medicines) – Presentation.

The URPTG

Version 2.0, October 2017

• Following extensive consultation –

§ A revised URPTG was published in October 2017 and § Implemented on 15 January 2018. Available online at https://www.tga.gov.au/publication/uniform-recall- procedure-therapeutic-goods-urptg-v20

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URPTG terminology

• Four types of recall actions are defined –

– Recall – Product Defect Correction – Hazard Alert – Product Defect Alert

• Four types of non-recall actions defined –

– Safety Alert – Product Notification – Quarantine – Product Withdrawal

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Types of recall actions

The four types of defined recall actions are:

• Recall – the permanent removal of deficient goods from the

market or from use

• Product Defect Correction – repair, modification, adjustment,

re-labelling, update to instructions for use

• Product Defect Alert – raise awareness of concerns, describe

actions to mitigate risks due to product deficiencies, may later be followed by a recall

• Hazard Alert – providing information to health practitioners

regarding issues with implantable medical devices and advice

• n how to manage recipient patients

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Recall examples

As published on the TGA website - https://www.tga.gov.au/all-alerts- sorted-date

Types of non-recall actions

The URPTG also defines the following four types of non-recall actions:

• Safety Alert – provides advice on the safe use of therapeutic goods in certain situations

where, although meeting all specifications / indications, its use could present an unreasonable risk of harm if specified precautions are not followed

• Product Notification - means the issue of precautionary information about a therapeutic

good, in a situation that is unlikely to involve significant adverse health consequences

• Quarantine - means the suspension of further supply pending investigation of an issue or
• incident. The outcome of the investigation will determine further actions and a recall may
• ccur after quarantine
• Product withdrawal - used to withdraw products for reasons that are not related to safety,

quality, efficacy, performance or presentation

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Recall Classification

• 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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Who identifies the issues?

• Sponsors
• Manufacturers through QMS implementation
• Other regulators notify the TGA as part of

international collaborative activities

• TGA via its post-market monitoring and compliance

activities, including lab testing

• Inspections of manufacturing sites
• Other e.g. complaints & ‘tip offs’

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Who’s responsible?

• We all are –
• Manufacturers
• Sponsors
• TGA

and all have varying responsibilities to ensure recalls are conducted in a timely and efficient manner which safeguards public health.

• The roles of these and other parties involved in recalls are

spelt out, in detail in the URPTG

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Manufacturer responsibilities

• Have established recall procedures in place
• Have an established relationship with the Australian sponsor
• Identify issues requiring recall or non-recall action
• Undertake the risk assessment (usually known as “Health

Hazard Evaluation or Assessment” - HHE / HHA)

• Identify the root cause and implement CAPA
• Have an effective QMS in place

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Sponsor responsibilities

• Take primary responsibility for the recall action
• Have an established relationship with the manufacturer
• Submits the proposed communication strategy and draft

recall letters for review

• Submits the manufacturer’s risk assessment
• Maintains and provides product distribution details
• Have established recall procedures in place
• Provides progress and close-out reports

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TGA responsibilities

• Undertakes independent review of the risk
• Reviews recall strategy & correspondence and provides

agreement to initiate the 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

• Publishes recalls in the SARA database
• Also publishes safety advisories for Hazard Alerts & consumer

level recalls (and others on a case by case basis) - https://www.tga.gov.au

• Reviews the root cause, CAPA and closes-out the recall action

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System of Australian Recall Actions

• SARA
• SARA – publically accessible database
• Provides stakeholders with access to information about Australian therapeutic

goods recall actions

• Holds information on recall actions undertaken since 1 July 2012
• User friendly and searchable across product types, names and date ranges
• Can be accessed from the TGA homepage - https://www.tga.gov.au or at

https://www.tga.gov.au/recall-actions

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Follow-up reporting

The recall reporting requirements are: – 2 week and 6 week progress reports; and – a close-out report at 3 months.

• Reports need to include:
• results of the recall
• the means of disposal, destruction or correction and

confirmation that this has occurred; and

• details of the root cause analysis and CAPA.

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Legislative provisions

Public notification & recall of therapeutic goods

• The Secretary’s powers and processes for mandating therapeutic goods

recalls relate not only to goods entered in the ARTG, but also to exempt, cancelled or illegally supplied goods

• Section 30EA: medicines
• Section 32HA: biologicals
• Section 41KA: medical devices

Note:

• Competition and Consumer Act 2010 (consumer goods)

– notification to ACCC for safety related actions

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Questions

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