Diagnostics new product development: overview, …...Dx new product development | 23 September 2013...

Dx new product development | 23 September 2013 1 |

Diagnostics new product development: overview, WHO’s scientific and

regulatory role, regulatory pathways and demand creation

Irena Prat

Technical Officer, PQDx


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

Another issue is the number of products available, with the large number of variations within a product range

the need to ensure safety and performance

timely availability of the latest technology


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.


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


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


GHTF regulatory model: key subsystems

These elements are interrelated and mutually interdependent.

PMS system

Risk-based PM

control

QMS and RM process encomp-assing

life cycle

Regulatory process to

periodically assess

conformity


Current harmonization

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

GHTF 2011 IMDRF


WHO PQDx process

Manufacturer submits application

Accepted

Rejected Application is screened

Manufacturer signs letter of agreement, pays fee and submits product dossier

Dossier is reviewed Accepted

Rejected

Manufacturing Site Inspection

Meets WHO requirements

Does not meet WHO

requirements

Meets WHO requirements

Does not meet WHO

requirements

Product is prequalified

Product Laboratory Evaluation

Post-market surveillance Figure 1: Overview of the prequalification of diagnostics process

PQ criteria


WHO PQDX regulatory framework

ISO and EN standards

GHTF / IMDRF

guidance documents

CLSI guidance documents

PQ requirements


PQDx advisory visits

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

Why?

How?

Who?


PQDx advisory visits

What?

PQDx requirements

Analyte-specific issues

Research and

development

The QMS, regulation

and certification


Documents under development

Information for manufacturers of innovative diagnostics

Advisory visits newsletter

Further guidance on product dossier submission


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


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


Thank you for your attention

Questions?

Diagnostics new product development: overview, …...Dx new product development | 23 September 2013...

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