proposed amendments to the new regulatory framework for in ... · ivd diagnostic market for...

Submis�ion to the TGA Consultation Pap�r

Proposed Amendments to the new regulatory framework for in vitro

Diagnostic Medical Devices (IVDs)

June 2013

GRIFOLS Table of Contents

Table of Contents ........................................................................... . . . . . . . . . . . .. . . . . . . . . . . . . ......... .......................... 2

Executive Summary ........................................................................... . . . . .................................................... 3

Grifols Australia Pty Ltd ................................... . . . . .......................... . . . . ........................................................ 4

Initial feedback on the proposed changes to IVD registration timeframes ................. . . .. . . . . . . . . . . . . . . . . . . . 6

Issue 1 - timeframe for valid applications for inclusion in the ARTG .... . . . . . . . . . . . . . . . . . . . . . . . . .............. ....... 9

Comments on the Current Situation regarding timeframes . . . . . . . . . . ......... .......................................... 9

Proposal 1A: staged transition to the new framework ...... ............................................................. 10

Proposal 18: retain existing timeframes for transition to new regulatory framework ............... 11

Issue 2: Regulatory requirements for Class 4 in-house ..................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .................. 12

Comments on Current Situation regarding Class 4 in-house IVDs . . . . . . ......... ............................... 12

Proposal 2A: A modified conformity assessment procedure for the regulation of Class 4 in-house IVDs predicated on commercial IVDs ........................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... ................. 13

Proposal 28: A modified conformity assessment procedure for the regulation of all Class 4 in-house IVDs . . . . . . . . . . .. . . . . . . . . . . . . . . . . . ....................................................................... . . . . . . . . . . . . . . . . . . . . . . . ................. 14

Proposal 2C: retain the current regulatory framework for Class 4 in-house IVDs ..................... 14

Issue 3: Performance evaluations for design examinations ............................................................ . . 15

Comments on Current Situation regarding Performance Evaluations ............. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Proposal 3: Selective performance evaluation of Class 4 IVDs that are submitted for design

examination .................................................. ..... . . . . . . . . . . . ......................................................................... 15

Issue 4: Regulation of tests for predisposition or susceptibility to disease .................................... 17

Proposal 4: Amend the definition of a medical device to include predisposition and susceptibility tests ............... . . . . . . . . . . . . . . . . . . . . . . . . . . . . ........ ............................................... . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . 17

Grifols Australia Pty Ltd - Response to TGA Consultation Paper for IVDs

GRIFOLS Executive Summary

Grifols Australia Pty Ltd is a local manufacturer and sponsor of the Grifols, S.A. products that are provided to the IVD segment in Australia and is impacted by the decisions of the Australian Government and the TGA with respect to IVD registration. We feel strongly about our responsibility to provide comment on the Consultation Paper - "Proposed amendments to the

new regulatory framework for in vitro Diagnostic Medical Devices (IVDs)" that was released on 3rd May 2013.

In considering our response to the suggested proposals, Grifols Australia Pty Ltd supports the Government policy to provide products and services to the Australian community of the highest quality and in a regulated environment.

There is a need to place a higher level of focus on the industry, be they commercial suppliers or providers of results, as we have an obligation to provide Australia with the highest quality products and services. We should take into account some of the characteristics of the local

market that supports Australia being globally recognized as a country that is supported with reagents, instrument systems and software solutions of the highest quality. The need for the provision of high quality pathology (diagnostic) sector must ensure that there is an appropriate level to scrutiny with the result being a commercially viable system with a minimized risk to the community.

However, that risk to the community must be balanced with a timely and resource efficient process that ensures that market entry is not unduly restricted by cost or timeline restraints.

Grifols Australia Pty Ltd supports;

Proposal 1A - a staged transition to the Framework. Grifols Australia recommends that the simplest implementation would be to extend the Transition Period for all IVDs to 301h June 2015.

Proposal 2A - a modified Conformity Assessment procedure for in-house Class 4 IVDs

based on a commercial Assay. Grifols Australia however seeks further information from TGA on the fees and charges that would apply to these proposed modified CAs.

Proposal 3 - Performance evaluations for Design Examinations. The requirement to undergo performance testing needs to be well justified if the products have TGA registration and not just duplicate data or testing that has already been provided or could be provided by the manufacturer and sponsor.

Grifols Australia cannot support Proposal 28 which would allow a different standard of assessment for de novo in-house Class 4 IVDs to that applied to identical commercial IVDs. Similarly, Proposal 2C which retains the status quo is not supported.


GRIFOLS Grifols Australia Pty Ltd

Grifols Australia Pty Ltd is an organization that is an Australian manufacturer of in vitro

diagnostic products and sponsor of in vitro diagnostic products from our affiliate company Grifols, S.A.. Our organization has in excess of twenty years' experience in the provision of products and services and support to the in vitro diagnostic market. In the last three years we have changed our identity as a result of the purchase of a local Australian business by Grifols, S.A..

Grifols Australia Pty Ltd has a dedicated team in our Head Office in Melbourne Australia and team members located nationally. Our team in Australia has undergone many changes and currently we have a team of 39 people. The team can be segmented into the following business unit segments:

Grifols Australia Pty Ltd Team Structure:

Administration and Customer Services Sales and Marketing Applications Technical Service Quality and Regulatory Management Manufacturing and Logistics Finance

Number of Staff members 4 5 5 8 3 11 3

Grifols, S.A., as Grifols Australia Pty Ltd, the new entity in Australia, has been focused on numerous internal and external requirements for the local business. Grifols Australia Pty Ltd has undertaken many activities to meet internal milestones and these have required prioritization. Our internal systems have determined that meeting regulatory requirements and client needs are the business priority. With Grifols, S.A. investment and decision to enter the Australian market directly, broad decisions have resulted in continuing investment in the business in Australia. This investment has been evident in the funding of the new Head Office, our new manufacturing facility and investment in the licensing of manufacturing of Blood Transfusion products in Australia by the TGA, increase of the range of products produced locally and enhancement of our commitment to pre-existing commitments for product development all in a self-contained business.

Grifols presence as a direct company also provides the local market with the added benefits of a global player in diagnostics with plans to have an extended range of products to those already supplied. This new investment has meant short term gains with a strong player providing Australian clients and the government with high quality and high value cutting edge products.

Grifols Australia Pty Ltd has met the needs of our local requirements and has negotiated to incorporate the need for IVD registration in the company's Global worldwide plans for both IVD's and clinical products undergoing registration. In the plans for the Australian business we have

products, instruments and services which are manufactured locally and products, services and instruments manufactured from our companies in other parts of the world. The alignment of the

global business needs, the impact on the local business, the need for implementation of standardization of manufacture and incorporation of global quality systems have all impacted our ability to prepare for the needs of IVD registration in Australia.


GRIFOLS Our ability to have the new facility TGA licensed was seen very positively, both from our clients and also from within the company. We have not only implemented new product manufacture using new equipment from our parent company, we have also successfully maintained our ISO 9001 accreditation and complied with ISO 13485 requirements to meet our obligation for our code of Good Manufacturing Practice (cGMP) licensing that has had challenges due to external timelines.

In our view the process of IVD registration has incorporated consultation, briefing sessions and planning of the community in question, but with the changes to our business it is our organizational view that this was outside of the management team within Grifols Australia Pty ltd. Comments and commitments that our representatives suggested were in relation to the pre-existing organization and without the knowledge of how our local business has changed. Thus this is the first time we as Grifols have been able to express our opinions and experience from other world markets as to the process, timelines and program of the Australian Government.

Grifols would like to express support for the shift in the proposed timeline modifications. Needless to say the Australian Government's plans for IVD registration have been an item for considerable discussion internally since the local business was acquired. Internationally we have been concerned that with the recent internal changes we would not be in the best position to meet the requirements, nor have the TGA be able to visit our facilities and ensure that our

product range would meet the initial timelines. We have already been required to modify the product availability in the marketplace from our range due to the need to have products listed on the ARTG prior to 2010. Thus the extension in time for full IVD registration needs also to revisit the strategy for new products, as the requirement to have these on the ARTG by 30 June 2010 disadvantages the marketplace for products that are currently available.


GRIFOLS Initial feedback on the proposed changes to IVD registration

timeframes

Grifols Australia Pty Ltd feels that our commitment in the Australian market needs to be considered by the Australian Government and the TGA, with this we have enclosed our comment and considered opinion in the Consultation Paper - Proposed amendments to the new regulatory framework for in vitro Diagnostic Medical Devices (IVDs).

The timing of the transition framework of IVD registration almost parallels our direct company involvement in the Australian market. This planned program was one of the issues that made it favorable for Grifols, S.A. to make our acquisition. We have a large amount of experience of doing business in other regions of the world where this stated outcome is not on the horizon and makes doing business for our organization difficult. Our Grifols, S.A. position was that local business reports emphasized the strength of the TGA and in delivering a high quality focused IVD diagnostic market for Australians, the fact that this planned IVD registration would positively impact the industry and enable quality focused organizations to have a sustainable business in this country. Our due diligence also confirmed that the planned IVD registration program would be of benefit from the global Grifols offering.

Post the full acquisition of the business it was clear that there are a number of issues that need to be addressed on a local situation to enable us to meet the organizational goals of IVD

registration. Internally we have expressed, on a number of occasions, concerns that the TGA program timing was not going to be easily achieved from the transition period to the full implementation of IVD registered products.

We have sought feedback from other companies and the industry body and felt that we were being represented to the TGA. We understand that our concern regarding the suggested timeframe was consistent with the market suggestions and due to our new situation in Australia we suggested that the IVD registration period should be increased or altered to enable a smooth transition without a negative impact to the Australian community;

• We have maintained vigilance on seeking updated information on the requirements for our products and services, but have been frustrated in the lack of clear direction and opportunity for feedback.

• We have kept abreast of the slow uptake of the transition from the pre 2010 listings to full IVD registrations by other companies. We have been working diligently in preparing our submissions but due to the implementation of new systems have been reticent to submit products for registration until we have confidence that the products would not be disadvantaged by changing requirements.

• Our currently available products are predominantly for higher risk (Class 3 and 4) IVDs,

and despite investment in training opportunities by the TGA and IVD Australia for members and non-members we feel that we are less than well prepared to meet the initial previously provided time frame;

• The initial suggested timeframe of IVD registration approval of June 2014 and the need to have Conformity Assessment and Design Examination applications to the TGA by June 2013 has seen many organizations apply in the most recent months. This was our strategy but for no other reason than we need the time as we are a new entity. The fact

that we have feedback that the TGA has now reached a crisis point as applications are not being finalised in time to meet the June 2014 deadline; and


GRIFOLS • Anecdotal information from IVD Australia in that a number of currently available

commercial IVDs will not be transitioned to the new framework due to the cost of doing so.

Clients in the diagnostic pathology market in Australia have also expressed a lack of enthusiasm for this TGA driven activity. The concern from the market is that they will be driven to have less choice of products and services. Clients have described situations that make them

feel uneasy and request us to confirm our commitment to the Australian market. This is driven by the fact that clients are more than aware that companies are deliberating on the decision to market products in this market with the advent of the process for IVD registrations. The market has already confirmed that the cost of IVD registration, TGA registration, quality process requirements and the need to provide more support for clients in using the products, is to be worn by the suppliers and sponsors and for an Australian market that represents less than 2% of the world market.

The costs of the provision of products and services with the associated on costs will make companies make business decisions on if maintaining the focus in this market is sustainable. IVD manufacturers and sponsors will take commercial considerations into account, including the market size and penetration, when making decisions to include or to not include IVD products on the Australian Register of Therapeutic Goods (ARTG).

Grifols Australia Pty Ltd accepts that the issues raised in the Consultation Paper are real and need to be addressed. However we are concerned that the need to address them does not;

• Create a situation where high risk (Class 4) in-house IVDs are subjected to a significantly less level of scrutiny than those of commercial manufacturers, this was not within the spirit of the long consultation process.

• We accept that for certain specific instances that with the fullness of time, understanding the individual circumstances and situations that the new recommendations as they appear under Proposal 28 should be discussed more broadly and robustly. We should not make IVDs registration processes stand in the way of this market development as a pioneer in the global market.

With respect to the use of in-house IVDs, we have been consulted as a local manufacturer for our view on being able to develop "in-house IVDs" and make them a commercial product. As a local manufacturer this is a risky strategy as we will assist clients but to make products that are not sustainable for broader marketing and thus our position on IVDs for in-house use is tempered by the reality that it will add costs to clients, which means that the focus turns to this process rather than utilizing commercial products appropriately.

Our most recent information is that the revised Standard covering the "Development and Use of

in-house in vitro Diagnostic Medical Devices (/VDs)" has not yet been released by the National Pathology Accreditation Advisory Committee (NPAAC). The latest information is that we expect that this will make significant strategic decisions on business segments that client participate in, the range of expectations on current suppliers of components of these such assays, these changes to the previous Standard are believed to be available for release post mid June 2013. Clients have expressed that until the standard is released and reviewed that the potential impact is unknown.


GRIFOLS Grifols Australia not only supplies Class 4 products, the fact that we would be required to have the on costs of TGA, ISO, cGMP, continuous improvement programs and the support

mechanisms for our clients which utilize the Class 1-3 products and need only to be regulated to NATA accreditation for Class 1-3 in-house IVDs does not seem to have all potential suppliers competing on level terms. We have assisted clients in preparation of NATA accreditation and would question if NATA accreditation has the appropriate level of scrutiny to determine the suitability of these assays.


GRIFOLS Issue 1 - timeframe for valid applications for inclusion in the ARTG

Comments on the Current Situation regarding timeframes

The current regulations regarding the transition of Class 4 commercial IVDs, regardless of if the source is from an Australian manufacturer or as the sponsor for commercially available products, these require the full assessment from the TGA, including the provision of the Conformity Assessment Certificate (CAC). The CAC is understood to be the certificate which provides feedback from the TGA that as a manufacturer the products and services are of the acceptable standard. The CAC supporting evidence is required before submitting their application for inclusion of a Class 4 IVD on the ARTG.

Once the application for inclusion on the Australian Register of Therapeutic Goods (ARTG) is submitted by the manufacturer or sponsor for a product/service with the CAC then it is considered to be a valid application and hence may continue to be supplied under the Transition arrangements. Similarly the registration transition has Australian manufactured Class 4 IVDs and products manufactured in other parts of the world have to receive a TGA CAC before making their applications for inclusion.

The concern of Grifols Australia Pty Ltd is that which the industry body IVD Australia and on feedback from the TGA, that with only 13 months to the end of the transition period, we are fast approaching unrealistic timeframes for the smooth transition. We have observed that in recent times we have obtained rulings and some further releases of information in relation to required materials, interpretations of rulings and clarity on some long standing issues which have yet to be resolved finally, this new information results in the time frames being compressed and

increasing making us nervous of the ever increasing short timelines.

We have provided feedback to IVD Australia that we have not been able to maintain our program to meet the TGA requirements in the said timeline. We have sought feedback from the TGA as to the strategies in relation to placement of our products onto the ARTG register and obtained different suggested strategy confirmations from the TGA, which has added to our internal timeframes when considering our product range for inclusion on the ARTG. We have many Class 4 commercial IVDs which due to our internal program could not yet apply for CAC application.

Given the current backlog of work within TGA (our estimate was that in excess of 38 CAC Applications and a corresponding 69 Design Examinations) it is unlikely that current in process applications and furthermore our submissions will be completed prior to 30 June 2014. Hence the potential is that many of our listed products may not receive their CAC in time to make an application for inclusion before the end of the transition period.

This may mean that a number of Class 4 assays used currently for screening the blood supply and other critical diagnostic purposes are not able to be supplied past July 151 2014.

Under the current arrangements, sponsors that submit applications for Class 4 products that are new to the Australia market are not considered separately to those applications involving transitioning products. Grifols Australia is concerned that this will cause significant delays to our ability to supply new Class 4 IVDs and may restrict availability of new technology to Australia health consumers.


GRIFOLS Proposal 1 A: staged transition to the new framework

Under Proposal 1A the TGA is proposing to extend the date for submission of valid Applications for inclusion for IVDs that require TGA Conformity Assessments until 30th June 2015. As the TGA has a statutory limit of 255 TGA working days, this would mean that manufacturers and sponsors would need to submit their applications for conformity assessment by end June 2014 at the latest.

Grifols Australia Pty Ltd is supportive of Proposal 1A. There is clear evidence that both TGA and IVD Australia, on behalf of its members, a number of sponsors of Class 4 commerciaiiVDs are struggling to meet the evidence requirements necessary for a CAC. On this information we have assumed that our submissions and those of other commercial organizations would be unlikely to meet the requirement of having either a completed inclusion on the ARTG or at least have a valid application.

The benefits of this proposal are that it will provide additional time for them to gather the evidence and to then submit a valid application by 30th June 2014.

The Consultation Paper makes no reference to Application Fees and to Annual Charges that would apply after 30th June 2014. Grifols Australia has sought to understand the potential costs of ARTG listings from IVD Australia, the feedback is that the normal CA application fees would apply and that Annual Charges would apply to any product included on the ARTG under this modified procedure.

The TGA statutory limit of 255 working days to undertake a Conformity Assessment equates to about one year. In view of the backlog of work at the TGA a major concern is that TGA still won't be able to complete all the applications for Conformity assessment, even for applications lodged during the first 6 months of 2013. Hence there will be products for which the sponsor has made genuine efforts to have their product included but who are unable to do so because TGA has not provided adequate resources.

Grifols Australia supports the view of IVD Australia with the suggestion that the simplest solution to the issue is of course to extend the transition period for ALL IVDs to 30th June 2015. This would mean that all sponsors, commercial or otherwise, would have an additional year to transition their products no matter what class. Adoption of this proposal would necessitate TGA engaging in an extensive education program to ensure that those manufacturers requiring a TGA CAC understood the timelines involved in the process and that applications for CA would need to be made within the next 12 months.


GRIFOLS Proposal 18: retain existing timeframes for transition to new regulatory

framework

Under Proposal 1 B (status quo) it is quite likely, and a commonly shared view, that a number of products will not be included on the ARTG before 30 June 2014. This is supported given the current TGA backlog and the rate at which applications are being processed.

The benefit to this proposal is that it requires no change to the regulations. Grifols Australia and other sponsors, who in good faith make applications within the current time frames may still not be able to supply their products as they expect. Those that have not undertaken the appropriate work will not be able to supply until they have received their CAC and have subsequently had their products included on the ARTG.

The risk of retaining the status quo is that there clearly will be some IVD products critical to the health and well-being of the community that are not able to be supplied for some period of time post June 301h 2014.

Grifols Australia Pty Ltd - Response to TGA Consultation Paper for IVDs Page 1 1

GRIFOLS Issue 2: Regulatory requirements for Class 4 in-house

Comments on Current Situation regarding Class 4 in-house IVDs

Over the consultation period and since this time it has become clear that there are a number of situations where commercial products are not available due to the niche need and the lack of market size within Australia. In these circumstances we assume that it will be difficult for testing laboratories that have a need for Class 4 IVDs, per the definitions, which have been manufactured as "in-house" solutions. Our view is that these laboratories do not have the expertise to obtain a TGA Conformity Assessment Certificate for these assays. These include assays that are initially based on a commercially supplied IVD but;

• that incorporate a modification of the assay instructions for use; and/or • that are performed on sample types not covered by the manufacturer's intended use;

and/or • that have an additional pre-analytical step; and/or • that use specimens outside the manufacturer's recommended storage conditions; and/or • that are intended by the manufacturer as a Class 3 IVD but are used as a Class 4 assay

for donor screening.

Grifols Australia shares the views with the industry body, IVD Australia, that in a number of these situations it will not be possible for testing laboratories to use the said assays. The issue is that due to the requirements commercial companies will not enable the items to be made due to the rigor and requirements of commercially supplied products. This being said then the IVDs would be lost for the testing laboratory and thus may cause issues in the release of sufficiently controlled tests, or the preparation of such detailed information deter users to apply for TGA conformity assessment.


GRIFOLS Proposal 2A: A modified conformity assessment procedure for the

regulation of Class 4 in-house IVDs predicated on commercial IVDs

Grifols Australia supports that IVD ARTG system needs to ensure that the standards and products need to be maintained in the future. To achieve the goal of IVD registration then

products of today and those in the future should be assessed to the same basic standards, thus the least amount of modification should be possible, thus we would prefer no changes to the agreed and legislated IVD framework. However we realise that is not practical at the present time in respect of some in-house IVDs that are based largely on the modification of commercially supplied IVDs.

We accept that, given that Proposal 1A is adopted in the format proposed by TGA it will also be necessary to extend the time that testing laboratories have to comply with the CA requirements. If an in-house IVD is based upon a commercial IVD, it will be necessary for the commercial IVD to be assessed by TGA before the commencement of the assessment of the in-house IVD using the modified CA procedure. Hence the Proposal that the cutoff date for inclusion of these assays be set at 30th June 2016 is reasonable.

However there must be adequate scrutiny of all suppliers of Class 4 products, be they commercial manufacturers, final testing laboratories that have through necessity indicated that they would take on the role as internal manufacture (by modification of commercial assays ) Class 4 in-house IVDs under this modified CA. This section is subject to many variables and against the stated IVD registration requirements, thus that the in-house manufacturer needs to be able to demonstrate compliance with this legislation. Grifols Australia cannot justify the added costs and need for compliance for commercial sites with insurance, quality systems and performance standards, compared to allowing in-house IVDs in Australia having solely NATA accreditation as a medical testing laboratory under ISO 15189.


GRIFOLS Proposal 28: A modified conformity assessment procedure for the

regulation of all Class 4 in-house IVDs

Grifols Australia Pty Ltd cannot support Proposal 28 which would mean that all Class 4 inhouse IVDs would be subject to the modified CA proposal developed in Proposal 2A.

Under this proposal new Class 4 in-house IVDs could be developed by labs with minimal scrutiny by TGA. This is exactly the situation that leads to the inclusion of in-house IVDs in the proposed regulatory framework in 2002 where incorrect results from an in-house HCV assay were detected. To accept Proposal 28 would permit high risk assays to be available for use without appropriate scrutiny and is not acceptable to IVD Australia.

We are also concerned that Proposal 28 creates an uneven playing field where a de novo Class 4 in-house IVD is not subject to the same Conformity assessment procedure as any commercial competitor.

Our belief is that laboratories must work with some commercial manufacturer to have both cGMP (or equivalent) as well as TGA rigor to release results that effect the donor and patient welfare, our understanding of NATA assessment and accreditation indicates that this suggestion would not be of equivalent standards. We must remind ourselves that we are considering this modification to potentially repeat the HCV experience in this country some years before. Manufacturing Class 4 IVDs need to build in the quality aspect which needs to be guaranteed, the development of in-house IVDs need to ensure that systems used to test the blood supply or bone and tissue donations or used for other high risk diagnostic purposes are well controlled and supported by Australian health consumers.

Proposal 2C: retain the current regulatory framework for Class 4 in-house

IVDs

Grifols Australia experience is that the suggested modified Conformity Assessment procedure in which ARTG registration for some Class 4 in-house IVDs is a potential but needs to be debated. The program should focus on what Class 4 in-house assays could be generated, what basic needs for ensuring quality need to be present in the design and manufacture of the test and what Assessment needs to be conducted.

Hence Grifols Australia cannot accept Proposal 2C as stated by the Australian Government.

The risk of retaining the current framework for all Class 4 in-house IVDs is that there will be no appropriately validated assays for some high risk indications which are not acceptable to any manufacturer as this is the rigor that we need to obtain to market such products if they were manufactured commercially. Thus in-house IVDs need to be able to show that they have the wherewithal to obtain TGA, DoHA and the Government and most importantly the Australian community.


GRIFOLS

Issue 3: Performance evaluations for design examinations

Comments on Current Situation regarding Performance Evaluations

Grifols Australia accepts that the current situation where the TGA has the ability to request samples of Class 4 IVDs for evaluation but has no legislative remit to require or undertake a performance evaluation as part of a design examination for a Class 4 IVD is not satisfactory and clearly an oversight when the IVD Regulatory framework was created.

Grifols Australia as a local manufacturer and importer of in vitro diagnostic solutions supports that value could be derived from local performance testing data, this may enable further support when assessing applications for design evaluation.

Proposal 3: Selective performance evaluation of Class 4 IVDs that are

submitted for design examination

Grifols Australia accepts the need to amend the regulations to allow for the performance testing of IVDs that are the subject of a design examination as we are strongly of the opinion that performance testing is not required for all class 4 IVDs as a general rule.

In particular the requirement to undergo performance testing needs to be well justified and not just duplicate data or testing that has already been provided by the manufacturer and sponsor. Performance testing by or on behalf of TGA can be justified only where;

• there is good evidence that something in the Australian population is significantly different to populations elsewhere; or

• where there is good evidence that new technology is significantly different to existing technology; and

• where the manufacturer has failed to provide adequate evidence to support the use of the assay with the Australian population

Grifols Australia believes also that TGA should provide clear examples of exactly what constitutes a "new technology" or a "novel indication for use". An "IVD designed to detect a serious infectious disease" would not necessarily be classified as a Class 4 IVD, and hence would not be subject to the need for performance evaluation. There is a need to have TGA provide guidance on what will be selected and what data and protocols TGA will be expecting in such circumstances. There is a need to ensure that demonstrating the safety of new assays and/or new technologies is balanced with access to state-of-the art healthcare technology.

Our experience would suggest that as a manufacturer our investigations and supporting development criteria should be sufficient when supplying data that would obviate the need for performance testing, unless the TGA can conclusively demonstrate that they have expertise above and beyond the manufacturer in the design, research and development of the in-vitro diagnostic system, that the TGA has evidence that the data supplied is limited in an important element and that further testing is required. In many cases the available market for a Class 4 IVD is quite small and to require testing in Australia may cost the manufacturer significantly more tests and resources than will be sold once the IVD has reached market and hence the performance testing will mean that the assay is commercially non-viable. In such cases


GRIFOLS manufacturers must have the option to supply data relevant to the Australian population and clinical practice that has been generated overseas. The consequence will be that sponsors will take the commercial decision not to introduce the product due to excessive costs. The subsequent impact will be that new technologies and markers might not be made available to the Australian community.

Alternatively, our suggestion is that TGA could provide samples which could be incorporated into the manufacturer's validation testing to allow for the data to be collected as part of the assay validation. In addition there would need to be guidance on the protocols to be adopted so that manufacturers can ensure that they are addressing TGA requirements should they choose to take this option.

However we believe that the risk of this proposal is that all Class 4 IVDs will be subjected to performance testing. This will lead to substantial expense for manufacturers and sponsors, the need for significant increase in TGA resources and ultimately to the detriment of the Australian community


GRIFOLS Issue 4: Regulation of tests for predisposition or susceptibility to

disease

Proposal 4: Amend the definition of a medical device to include

predisposition and susceptibility tests

TGA has identified that there was an oversight in the drafting of the IVD Regulations that predisposition and susceptibility tests were apparently overlooked when reviewing the definition

of medical devices, although they are captured in the definition of an IVD.

Hence Grifols Australia supports the amendment of the definition of a medical device to incorporate these tests. We do not believe that the proposed change will have any effect other than to clarify the regulatory situation of these types of IVDs and provide a benefit in ensuring that this technology can be appropriately regulated without confusion. We foresee no risks from the proposed change.


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