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

Joshan JoyActing Director, Recalls and Case Management SectionManufacturing Quality BranchMedical Devices and Product Quality Division, TGAARCS Scientific Congress Canberra 2016

10 - 11 August 2016

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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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 URPTGARCS Scientific Congress Canberra 2016 3

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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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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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Recall actions – changesThe 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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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 deathClass

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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Process for biologicals and other immediate actions Immediate

and significant threat

Actual (or potential) product

tampering

Human blood or a blood

componentBiologicals Radiopharmaceuticals

Contact the Australian Recall Co-ordinator

Contact Customers

Implement and report on the agreed recall strategy

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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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Legislative contextMost 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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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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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 placeARCS Scientific Congress Canberra 2016

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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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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 actionARCS Scientific Congress Canberra 2016

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Follow-up reportingThe 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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Number of recall actions

Jul-Dec 14 Jan-Jun 15 Jul-Dec 15 Jan-Jun 160

50

100

150

200

250

300

350

Cou

nt

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Recalls vs ARTG entries – devices and medicines

Jun-Dec 14 Jan-Jun 15 Jul-Dec 15 Jan-Jun 160

0.001

0.002

0.003

0.004

0.005

0.006

0.007

0.008

Recall Ratio - Devices

Recall Ratio - Medicines

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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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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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Questions

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