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 3

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 4

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 on how to manage recipient patients 5

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 occur after quarantine • Product withdrawal - used to withdraw products for reasons that are not related to safety, quality, efficacy, performance or presentation 7

Recall Classification • a situation in which there is a reasonable Class probability that the use of, or exposure to, a I deficient product will cause serious adverse health consequences or death • a situation in which use of, or exposure to, a deficient product may cause temporary or Class medically reversible adverse health II consequences or where the probability of serious adverse health consequences is remote • a situation in which use of, or exposure to, the Class deficient product is not likely to cause adverse III health consequences 8

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’ 9

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 10

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 11

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 12

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 13

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 14

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 . 15

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 16

Questions 17