Medsafe – GMP update /
release for supply /
communicating quality issues
Derek Fitzgerald
Manager, Compliance
Management
11 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 Authority
Relevant legislation – Medicines Act 1981,
Medicines Regulations 1984
Comprises several ‘Branches’
Compliance Management
Product Regulation
Clinical Risk Management
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CMB – area of operation
GMP audit and licensing / certification
Medicines and medical devices complaints &
recalls
Investigations and prosecutions
Medicines testing programme
Medical devices listing database (WAND)
Advertising complaints and issues
Advice on legislation and policy
Legislative compliance
Border control
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CMB Teams
Product Safety (Wellington) (8 staff)
Post-market complaints, recalls & market actions
GMP
Medicines testing programme
Medical devices – WAND
Advertising issues
Supply of unapproved products
Investigations & Enforcement Team
(Auckland) (5 staff)
Investigations and prosecutions
Border 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 Scene
Currently around 50 ‘active’ sites
Wide range of manufacturing operations
8 API – including clinical trials, biologicals
10 complementary medicines
8 blood service or similar
5 gas sites
2 overseas
4 testing laboratories
10 packing sites
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GMP operations
Medsafe performs around 50 audits
annually with 3 auditors (recent increase)
Audit frequency is determined through risk
assessment performed at each audit
Various mechanisms used to ensure
resolution of GMP issues is achieved
Ongoing interaction and follow up is
common
Growing requirement for advice on postmarket issues
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GMP developments
Now a PIC/s member
ANZTPA B2B – B4
Information sharing
Joint training
Joint audits
Future 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 process
Currently NZ and Australia are closely
aligned with respect to Good
Manufacturing Practice
10
Trans-Tasman GMP relationship
Over 2 decades of cooperation
Close GMP alignment
Strong relationship build up to ANZTPA #1
Being a competent and credible small GMP
regulator requires close relationships and
cooperation with others
Looking 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
12
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)
13
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 market
Failure to meet current approved
specifications
Off-shore actions creating liability in NZ
Failure to understand responsibility
Need to fully understand products, GMP /
technical issues and legal issues
15
Contractual arrangements
Distribution chain can be complex
Need to ensure technical
arrangements are met and
responsibility clear
Flexible – several models of operation
accepted
16
Process summary
A licensed NZ entity responsible for market
release
NZ approved product details are held
Stock is received into quarantine
C of A is received and compared with
approved details
Batch is identified and labelling is examined
Release 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 questions
Ensuring a clear line of communication between
manufacturing site / NZ sponsor / Medsafe
The NZ sponsor is legally responsible
Rapid response is required – even if full answers
may take time
Risk assessment based on product knowledge –
important
Effective 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 explanation
We are looking for you to demonstrate
competence in handling issues
We look at what you send and assess it
Important to be consistent
Be honest
Ensure 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 far
Ensure clinical assessment is provided, if
appropriate
Distribution details are important
Identify the possible manufacturing issues
Be clear about testing performed / planned
Provide rationale for possible explanations and for
ruling out possibilities
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Thank you
Contact details:
Medsafe website: www.medsafe.govt.nz
Email contacts for specific questions
GMP: askmedsafe@moh.govt.nz
Product Safety Team: recalls@moh.govt.nz
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