Medsafe – GMP update / release for supply /

communicating quality issues

Derek FitzgeraldManager, Compliance Management11 July 2013

RACI Pharmaceutical Science Group (NSW)

Medsafe and GMP

Medsafe – an introduction GMP update Release for supply – New Zealand Communicating quality issues

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Medsafe

The New Zealand Medicines and Medical Devices Safety AuthorityRelevant legislation – Medicines Act 1981, Medicines Regulations 1984Comprises several ‘Branches’

Compliance ManagementProduct RegulationClinical Risk Management

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CMB – area of operationGMP audit and licensing / certificationMedicines and medical devices complaints & recallsInvestigations and prosecutionsMedicines testing programmeMedical devices listing database (WAND)Advertising complaints and issuesAdvice on legislation and policyLegislative complianceBorder control

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CMB TeamsProduct Safety (Wellington) (8 staff)

Post-market complaints, recalls & market actionsGMPMedicines testing programmeMedical devices – WANDAdvertising issuesSupply of unapproved products

Investigations & Enforcement Team (Auckland) (5 staff)

Investigations and prosecutionsBorder control and importation

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Some post-market statistics

For the full financial year: Jul 2012 – Jun 2013• Medicines incidents handled / closed: 478,

of which 29 were recalls• Medical devices incidents handled / closed:

1,067, of which 284 were recalls or market actions

• GMP audits conducted: 49• Packages inspected at the border: 11,500

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The New Zealand GMP SceneCurrently around 50 ‘active’ sites Wide range of manufacturing operations8 API – including clinical trials, biologicals10 complementary medicines8 blood service or similar5 gas sites2 overseas4 testing laboratories10 packing sites

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GMP operationsMedsafe performs around 50 audits annually with 3 auditors (recent increase)Audit frequency is determined through risk assessment performed at each auditVarious mechanisms used to ensure resolution of GMP issues is achievedOngoing interaction and follow up is commonGrowing requirement for advice on post-market issues 8

GMP developments Now a PIC/s member ANZTPA B2B – B4

Information sharingJoint trainingJoint auditsFuture alignment of processes

Closer relationship with TGA Application to EU in respect of API third country exemption status

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ANZTPA

Intention of both Governments to proceed with the establishment of a joint agency Key points – Joint Agency, new / updated legislation (especially for New Zealand)Work is underway on planning the establishment processCurrently NZ and Australia are closely aligned with respect to Good Manufacturing Practice

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Trans-Tasman GMP relationshipOver 2 decades of cooperationClose GMP alignment Strong relationship build up to ANZTPA #1 Being a competent and credible small GMP regulator requires close relationships and cooperation with othersLooking forward to a continuing and growing relationship

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Release for supply in NZ - overview

Legislative requirements Licensing of ‘sponsors’ Issues noted GMP / contractual arrangements Process

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Legislative requirements

Sale of a medicine Requirement to be licensed Section 42 – specifications and testing Sections 20 and 24 – product approval Recall and other market actions (regulation 50)

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Licensing of sponsors

Licence to Sell Medicines by Wholesale Audits carried out by Ministry of Health Monitoring of compliance through interactions during quality investigations / recalls

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Issues noted

Stock imported and distributed when not for the NZ marketFailure to meet current approved specificationsOff-shore actions creating liability in NZFailure to understand responsibilityNeed to fully understand products, GMP / technical issues and legal issues

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Contractual arrangements

Distribution chain can be complex Need to ensure technical arrangements are met and responsibility clear Flexible – several models of operation accepted

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Process summaryA licensed NZ entity responsible for market releaseNZ approved product details are heldStock is received into quarantineC of A is received and compared with approved detailsBatch is identified and labelling is examinedRelease can be made

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Communicating quality issues

Responding to the regulator Responding to a market issue Dealing with issues successfully Response is important and determines the level of confidence a regulator can have in a manufacturer / sponsor

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Responding to quality issues - when the regulator has questionsEnsuring a clear line of communication between manufacturing site / NZ sponsor / MedsafeThe NZ sponsor is legally responsibleRapid response is required – even if full answers may take timeRisk assessment based on product knowledge – importantEffective action in the distribution chain

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Responding to market quality issues

How is a quality complaint received? Who is involved in making early decisions? Ensure rapid risk assessment Systems should be integrated – production, marketing, distribution, clinical, QA How will decisions be made?

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Regulatory expectations

Medsafe has the expertise to understand your explanationWe are looking for you to demonstrate competence in handling issuesWe look at what you send and assess itImportant to be consistentBe honestEnsure all questions are answered

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A good technical response

There should be a clear description of the problem Describe the investigation so farEnsure clinical assessment is provided, if appropriateDistribution details are importantIdentify the possible manufacturing issuesBe clear about testing performed / plannedProvide rationale for possible explanations and for ruling out possibilities

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Thank you

Contact details:Medsafe website: www.medsafe.govt.nzEmail contacts for specific questionsGMP: askmedsafe@moh.govt.nzProduct Safety Team: recalls@moh.govt.nz

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