Diagnostics new product development:
overview, WHO’s scientific and
regulatory role, regulatory pathways and
demand creation
Irena Prat
Technical Officer, PQDx
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Dx new product development | 23 September 2013
Global Dx regulatory landscape
 Dx regulation is relatively new for many jurisdictions and the degree
of harmonization is suboptimal, although improving
 In the rapidly evolving world of technology, the rate of change in Dx
design and development is high, and this provides a major challenge
in maintaining a balance between
timely availability of the latest
technology
the need to ensure safety
and performance
 Another issue is the number of products available, with the large
number of variations within a product range
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Dx new product development | 23 September 2013
Harmonization history
 1993: senior regulatory officials and industry representatives from the EU, USA,
Canada, Japan and Australia established a global consultative partnership aimed
at harmonizing medical device regulatory practices: GHTF
 The GHTF was a voluntary group of representatives from national medical device
regulatory authorities and the regulated industry
 The purpose of the GHTF was to encourage convergence in regulatory practices
related to ensuring the safety, effectiveness/performance and quality of MD,
promoting technological innovation and facilitating international trade.
 The primary way in which this was accomplished was via the publication and
dissemination of harmonized guidance documents on basic regulatory
practices.
 Guidance principles can be adopted/implemented by NRAs.
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Dx new product development | 23 September 2013
The GHTF
 5 GHTF Study Groups
–
–
–
–
–
Study Group 1 - Premarket Evaluation
Study Group 2 - Post-Market Surveillance/Vigilance
Study Group 3 - Quality Systems
Study Group 4 - Auditing
Study Group 5 - Clinical Safety/Performance
 The GHTF regulatory model
– the core and basic elements
– Supported by GHTF guidance documents
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Dx new product development | 23 September 2013
Dx life cycle
development is a continuous process from
the initial concept of the device
 to the various phases of product
realization
 to placing the device on the market
 to marketing of the product through
distribution, promotion, advertising,
servicing
 to obsolescence or renewal as a
modified product
The entire cycle is subject to the
regulatory processes of a (QMS), RM, and
regulatory auditing
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Dx new product development | 23 September 2013
GHTF regulatory model: key subsystems
Riskbased PM
control
PMS
system
QMS
and RM
process
encompassing
life cycle
Regulatory
process to
periodically
assess
conformity
These elements are interrelated and mutually
interdependent.
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Dx new product development | 23 September 2013
Current harmonization
GHTF
2011
IMDRF
 IMDRF:
– a regulator-led harmonization and collaboration group that would allow for
more detailed discussion between members on the optimum ways to achieve
harmonization at an operational level
– Australia, Brazil, Canada, Europe, Japan, USA, China and Russia; WHO is an
official observer
– Working Groups are established by the Management Committee and operate
under targeted mandates on specific activities
 Other harmonization groups: AHWP
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Dx new product development | 23 September 2013
WHO PQDx process
Manufacturer
submits application
Rejected
Application
is screened
Manufacturer signs letter of
agreement, pays fee and
submits product dossier
Accepted
Rejected
Dossier is reviewed
Accepted
Does not meet
WHO
requirements
Manufacturing Site Inspection
Meets WHO
requirements
Meets WHO
requirements
Product is prequalified
Post-market surveillance
Figure 1: Overview of the prequalification of diagnostics process
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Dx new product development | 23 September 2013
Does not meet
WHO
requirements
PQ criteria
Product Laboratory Evaluation
WHO PQDX regulatory framework
ISO and EN
standards
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GHTF /
IMDRF
guidance
documents
Dx new product development | 23 September 2013
CLSI guidance
documents
PQ
requirements
PQDx advisory visits
Why?
How?
Who?
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To exchange information with R&D teams and Mx in the early
stages of development of a Dx, with a view to facilitating entry
into the PQDx and meeting int. regulatory requirements
Focuses on review of the current status of the company, and
then in that context, the advisory team explains the specific
requirements for PQDx in relation to the dossier submission,
site inspection and performance evaluations.
Experts in QMS, R&D, production and technology of the Dx
involved
Dx new product development | 23 September 2013
PQDx advisory visits
What?
Analytespecific
issues
PQDx
requirements
The QMS,
regulation
and
certification
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Dx new product development | 23 September 2013
Research
and
development
Documents under development
 Information for manufacturers of innovative diagnostics
 Advisory visits newsletter
 Further guidance on product dossier submission
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Dx new product development | 23 September 2013
Regulatory pathways for Mx
 PQDx is aligned with SRAs regulatory requirements
– Specific PQ aspects (stability, IFU, customer-related issues etc.)
are addressed from a different prospective
 Regulatory pathways required by SRAs also lead to compliance with
PQDx;
– Mx following SRAs requirements are on the good way to meet
PQ requirements
 To meet the demand for innovative Dx market access:
– Advisory visits to Mx
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Dx new product development | 23 September 2013
Capacity building in countries
 PQDX pilot project on pre- and post-market regulation
capacity building
 Focuses on 5 countries with several other MS involved
 Building a regulatory framework in line with best
international practice
 Ensuring understanding of regulatory practice and
avoiding duplication of work
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Dx new product development | 23 September 2013
Thank you for your attention
Questions?
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Dx new product development | 23 September 2013