European Business Council (EBC) Medical Devices
and IVD Committee

Meeting of Representatives
Report by IVD Subcommittee
December 8th 2022
Vice Chairperson in charge : Shinichi Eda
Subcommittee Chairperson : Miwa Nishida

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Agenda1. Outline of IVD Committee⚫ IVD Subcommittee Basic Activity Policy⚫ WG members➢ Regulatory Affairs WG➢ Reimbursement WG

2. Results of Activities in 2022
⚫ Related to Regulatory Affairs WG⚫ Related to Reimbursement WG

3. Activity Plan for 2023

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1. Outline of IVD Subcommittee

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Basic activity policy of the IVD Subcommittee⚫ Working with the JACRI (Japan Association ofClinical Reagents Industries) and the AMDD IVD
Committee, the three organizations in the IVD
industry strengthened their appeal to thegovernment.

⚫ Active Participation in the Activities of Three
Industry Organizations as EBC Representatives⚫ EBC-Led Proposals

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2. Results of Activities in 2022⚫

Regulatory Affairs WG

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Regulatory Affairs WG : Overview of activities in 2022
⚫ Regulatory Affairs WG• Regulatory Affairs WG take place the meeting 8 times (all web
meeting)⚫ Activities of the Regulatory Affairs WG• Exchange of Opinions on the Revision of the Pharmaceuticaland Medical Devices Act• Handling of IVD in the Pharmaceutical and Medical
Devices Act• Review of IVD definitions• Exchange of opinions on consultation for revision of IFU(Tempu-bunsho)• Exchange of opinions on "Drug-Agnostic Companion
Diagnostics”• Exchange of opinions on PMDA consultation and inquiry

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Activities as three IVD industry organizations
I.

Periodic opinion exchange meeting on regulatory review and safetymeasures for medical devices and IVDs : 1 Sep 2022 ≫ Page 9-12

II.

Working Level Conference for Collaborative Plan ≫ Page 13-16➢ 2021 1st Working Level Conference : 9 Jan 2022
➢ 2022 1st Working Level Conference : 13 Jul 2022

III.

Exchange of opinions on Drug-Agnostic Companion Diagnostics➢ Notification issued : 31 Mar 2022
➢ PMDA guidance issued : 4 Jul 2022
➢ Pilot examination of operation is ongoingIV.

Regular meetings (monthly) with the Safety Division of MHLW andthe office of Manufacturing Quality and Vigilance for Medical in PMDA
➢ Consideration of changing the reporting of adverse reactions toreporting of adverse events➢ Consultation on revision of IFU (Tempu-bunsho) for in-vitro diagnostics

V.

Exchange of opinions on the next revision of the Pharmaceutical andMedical Devices Act ≫ Page 17
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I.

Regular opinion exchange meeting (1 Sep 2022) @ Web

Opinions and requests from the in-vitro diagnostic industry
1. Lessons from COVID-19
2. Review of categories for pathogen gene testing
3. Regulations tailored to the characteristics of IVDs - with aview to PMD Act revisions
3-1. Revision of the definition of in-vitro diagnostics
3-2. Review of qualification requirements for
management representative

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I.

Regular opinion exchange meeting (1 Sep 2022) @ Web

1. Lessons from the COVID-19
Requests•

When considering system development, please involve the in-vitro diagnostic industry
that takes charge of development and supply of test reagents.
✓ It is considered that a more prompt and flexible response will be made possible byproviding opportunities for system development on the side of the diagnostics
industry at an early stage.
✓ It is expected that more companies will contribute and the response will be speeded
up by integrating the contact point of the administrative side and the industry sideand developing a system to transmit and collect necessary information in a timely
and efficient manner.

•

Since it is necessary to promptly and widely obtain reagents and products at local andabroad in case of emergency, it would be very useful to. have specific notifications inboth Japanese and English in order to clearly convey emergency response information
to overseas companies•

Taking the opportunity of the establishment of the Japanese CDC as an opportunity, we
would like to discuss how infectious disease-related tests including product reviews
should be conducted in Japan.

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I.

Regular opinion exchange meeting (1 Sep 2022) @ Web

2. Review of categories for pathogen genes testing
Requests
Items related to genetic testing and measurement methods for pathogens should beclassified not as products outside the approval standards only because of genetic testing,but as review categories according to their characteristics.
✓ New pathogen genetic test items are new items✓ For items other than new products, classification is set according to thecharacteristics of the item.
✓ However, even if the inspection items are already known, but there is no correlation
with the approved products or the measurement principle is clearly different, theproduct will be considered as “ non-conforming product”.

Page10I.

Regular opinion exchange meeting (1 Sep 2022) @ Web

3. Regulations according to the characteristics of in-vitro
diagnosis - with a view to PMD Act revision 3-1. Review of the definition of in-vitro diagnostics
Requests
discuss review the definition of in-vitro diagnostics and establishment of appropriate review requirements
according to the intended use and risks taking into account the diversification of the purpose of clinicallaboratory tests and the consistency with foreign regulations.

3-2. Qualification Requirements for Management representative
Requests•
It is once again requested that the criteria for IVD-MAH-general, manufacturing supervisors in the
manufacturing industry, and managers in the wholesale business should not be limited to pharmacists,
but should be defined in the MHLW ordinances that is a person who meet any of the following criteria,:(I) A pharmacist(ii) Physician, dentist, veterinarian, clinical laboratory technician(iii) A person who has completed a specialized course in clinical laboratory science, chemistry, biology,
immunology, biochemistry, microbiology, or pharmacology at a university etc. ;(iv) A person who has experience in engaging in the work of quality control or post-marketing safetycontrol of in-vitro diagnostics for three (3) years or more after graduating from a former secondary
school, a high school, or a school equivalent or greater than the same by completing a specialized
course in clinical laboratory science, chemistry, biology, immunology, biochemistry, microbiology, or
pharmacology.
•

discuss the role of the MAH-general of in-vitro diagnostics too in the ongoing " Study on Review of
Qualification Requirements for the MAH-general of Medical Devices ".
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II. Working Level Conference for Collaborative Plan
2021 First Working Level Conference (9 Jan 2022) @ Web
1.

Confirmation of Progress of Collaborative Plan Efforts

2.

Exchange of Opinions on the PMDA Consultation System➢

3.

PMDA consultation satisfaction survey : Generally satisfied. There was a slightdecrease from the previous time.

Exchange of opinions on the publishing system for publishing IFU(Tempu-bunsho) information➢ Request for system improvement so that it can be disclosed on the same day➢ Request to support XML file format

4.

Time clock survey

2022 First Working Level Conference (13 Jul 2022) @ Web
1.

Confirmation of Progress of Collaborative Plan Efforts2.

Proposal for Review of Review Categories for Pathogen Gene testing

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II. Working Level Conference for Collaborative Plan
Time clock survey

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II. Challenges of the Collaborative Plan
~ Roadmap ① ~Fiscal2020

Item

Fiscal 2021

Optimization of IVD scope

1-1

Procedures for Exclusionfrom Designation of
Poisonous and Deleterious
Substances

1-2

II

Reliability assurance of
application data

1-3

2019/12/10 Briefing session : Completed

Development of Guidelines
for Clinical Performance
Tests

1-4

Review of CDx

1-5

Fiscal 2022
II

I
III

IV / VIIIII / IV / V

Investment Consultation and Explanatory
Meeting

III

IV / VIII

I
II

Fiscal 2023

I

II / III /
IV

V

III

IV

V

IV / V
Agreement on the
direction of response to
notification concerning
stability test
Dissemination at seminars ofagreed items such as
examination requirements andstandards conducted every year

International harmonizationof Examination
Requirements andStandards

1-6

Review of operation of preapproval tests

1-7

Modification of FD
application software

1-8

Scope expansion of clinicalsignificance of IVD

1-9

I

II

III / IV / V

Creation of New Approval
Conditions

1-10

I

II

III / IV / V

2019/10/3 Notification issued / Dissemination : Completed
Drastic review of operation : I

IIIII / IV / V

Request for modification submitted in
December every year

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II. Challenges of the Collaborative Plan
~ Roadmap ② ~Fiscal2020

Item

Fiscal 2021

Review of Classification

1-11

Approval system basedon the characteristics of
IVD

1-12

Development of items foroverseas epidemic
infectious diseases

1-13

Indication of common
reagent

2-1

Achievement of targets
for the standard total
review period

3-1

Full year

Improvement ofconsultation system
Effective utilization

3-2

Full year

On the review andapplication sides
Skill Improvement

3-3

PMDA Operational
Efficiency /Rationalization

3-4

Fiscal 2022

Fiscal 2023

I / II / III

IV / V
Indication of presenceor absence of IVD
applicable products

I

II

III

III / IV / V

IIIII / IV / V

III / IV/V

III / IV / V

Matters agreed upon, such as examination requirements andstandards Holding seminars (annually)
Full year[ Image of phase ]I analysis ofcurrent
situation

II Formulation of
plan

III. Draft s
Preparation

IV .
Completed

V . Publicity andeffect measurement

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V. Exchange of Opinions on the Next Revision of
the Pharmaceutical and Medical Devices Act
Meeting with the Evaluation and Licensing Division of Medical Devices,
Pharmaceutical and Food Safety Bureau, MHLW◆First meeting : August 31◆

Second meeting : October 5◆

Third meeting : November 16

Timeline for Revision of the Pharmaceuticals andMedical Devices Act◼ R4 : Determination of direction of legal revision◼ R5 : System Committee◼ R6 : ordinary session of the Diet

Participants : MHLW, PMDA, IVD industry representatives<Contents>◆ Currently, in-vitro diagnostics are classified as "pharmaceuticals". However, fromthe viewpoint of substantial regulations and international consistency, it isconsidered to exclude them from " pharmaceuticals"◆ Consider separate classification as " In-vitro diagnostic products (tentative name) "instead of classification as " medical devices "◆ In principle, what is currently being done shall be kept as is. After that, we will
improve where we can improve.
✓ Administrator requirements, IVD definitions, clinical performance test
guidelines, etc.
◆ Investigate the affected parts / impacts inside and outside the Pharmaceutical andMedical Devices Act when products are removed from " pharmaceuticals " andconsider countermeasures.

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2. Results of Activities in 2022⚫

Related to Reimbursement WG

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Reimbursement WG : Overview of Activities in 2022

⚫ Reimbursement Working Group• WG meetings held three times (all web meeting)⚫ Activities of the Reimbursement Working Group• R4 Reimbursement revision : Confirmation of related notification• Identification and proposal of issues to be addressed for the R6 Reimbursement
revision• Participate in joint working group of JACRI/ AMDD/EBC and consider request for
R6 Reimbursement revision➢ Working Group A : Innovation Evaluation (Challenge Application)➢ Working Group B : Innovation Evaluation (Usefulness of test and
Evaluation axis of Innovativeness)
EBC Lead➢ Working Group C : Value and Evaluation of POCT Testing
EBC Lead➢ Working Group D : Handling of tumor-related genetic tests➢ Working Group E : Value of Test in AMR Measures➢ Working Group F : Rationalization of insurance application examination(process)

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Activities as three IVD industry organizations⚫ JACRI/AMDD/EBC: Joint Medical Insurance System Committee➢➢➢➢

Participation in 10 meetings of the committee
Identification of issues / requests as an IVD industry group toward the R6
Reimbursement revision
Agreement to establish a joint working group of the three organizations to study
the matter
Administrative Response as IVD Industry Organizations⚫ Exchange of opinions with the Pharmaceutical Industry Promotionand Medical Information Planning Division, Health Policy Bureau,
MHLW for the regular meeting : 22 Sep 2022
⚫ The 3rd Public-Private Dialogue for the Creation of Innovative
Medical Devices: 28 Nov 2022 ≫ Page 21-23
A)

Innovation Assessment for Clinical Laboratory testingB)

Measures against the next infectious disease crises

C)

Measures for Stable Supply in Times of Price Increases

Page19Public-Private Dialogue for the Creation of
Innovative Medical Devices
A : Evaluation of innovation for clinical laboratory testing
As stated in the Recommendations Concerning a Proper Implementation System for Clinical Laboratory Tests," Definition of Innovation of Test, Transparency based on it, and Introduction of Valid Evaluation Criteria " arevery important for the creation of innovative in-vitro diagnostics.
Current status• Even if innovative products are developed for in-vitro diagnostics, the mechanism for evaluating themhas not been clarified.
(Medical Device: Innovative premium, improvement premium, marketability premium, etc.)

Status• Motivation to develop next-generation products cannot be maintained because the development costs
for continuing to develop innovative in-vitro diagnostic reagent accompanying recent advances inscience and technology that can contribute to patients and medical facilities cannot be secured andthe predictability of incentives for development cannot be secured.
• At the statement of General Assembly of Chuikyo on May 18, 2022, according to the opinion attachedto the report, the evaluation of innovations such as testing will be considered by the Insurance
Medical Materials Subcommittee.

≪Proposal ≫• consider to evaluate innovation and reflect it in medical fee points for in-vitro diagnostics
by the Insurance Medical Materials Subcommittee.
Step1 : Agree on the definition of innovation for clinical testing
Step 2: Institutionalize additions to items that meet the definition of innovation

Page20Public-Private Dialogue for the Creation of
Innovative Medical Devices
B Measures for the Next Infectious Disease Crisis (Lessons from COVID-19)
As a measure against the next infectious disease crisis, it is extremely important to continue to develop
and strengthen the examination system, including the maintenance of measuring instruments and humanresources that have been developed and secured in medical institutions.
Current status
As preparation for the next infectious disease crisis, the COVID-19 Response Headquarters has raised thefollowing issues for the purpose of " Strengthening the Testing System " .
••In order to ensure that tests are conducted smoothly from the initial stage of infection, the testing
system will be drastically strengthened by developing the necessary systems by prefectures andpromoting the utilization of private clinical testing labolatories.
Develop a framework for taking appropriate measures for the production and import of reagents,
test kits and other goods necessary for tests in emergencies.

≪Proposal≫• When considering the establishment of a system, we are in charge of the development and supply of
test reagents and the diagnostics industry would like to participate in the discussion at an earlystage.
- It is expected that more companies’ contribution and the response will be speeded up by
unifying the contact points for administrative and industry sides and developing a system totransmit and collect necessary information in a timely and efficient manner.
- Providing opportunities for the development of systems on the part of the diagnostics industry
at an early stage will enable a more prompt and flexible response.
•

As a risk management measures implementation of " maintenance of testing instruments, etc. " and" recruitment and training of clinical laboratory specialists and clinical laboratory technicians " inmedical institutions in peacetime (including maintenance of equipment and human resources thathave been improved recently) is recommended.
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Public-Private Dialogue for the Creation of
Innovative Medical Devices
C. Measures for Stable Supply in the times of Price Increases
Recent environmental changes such as rapid exchange rate fluctuations
Background•

Recent changes in the environment

Increased costs for imported goods and raw
materials procurement due to the sharp
depreciation of the yen•

Even for member companies of the JACRI, theimpact of fluctuations in foreign exchange
rates and consumer prices will increase costs
by about 10-30%.

•

Under public medical insurance withreimbursement prices, it is difficult to pass onthese cost increases to medical institutions byraising selling prices.

••

Effects of COVID-19
High commodity prices due to disruption of
distribution networks(Cost increases of 2-4 times for airfreightand 2-5 times for sea freight)

Request for Immediate Measures• Development of an environment that facilitates the use of Temporary Subsidies forReginal Development by medical institutions• This is within the framework of public medical insurance, but we would like to pass on
increased costs to sales prices.
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3. 2023 Activity Plan

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Regulatory Affairs WG : Activity Plan for 2023⚫

Promotion of Efforts under the Second Collaborative Plan
➢ International Coordination of Regulatory Requirements andStandards⚫

Next review for revision of the Pharmaceutical and Medical
Devices Act➢ Handling category of in-vitro diagnostics➢ Scope / Definitions and Application Requirements for In-Vitro
Diagnostics⚫

Initiatives for the implementation of Drug-Agnostic Companion
Diagnostics➢ Participation in Pilot Operations⚫

Deepening understanding of overseas regulations and promotinginternational harmonization

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Reimbursement WG : Activity Plan for 2023

⚫ Strategic Activities for the R6 Reimbursement Revision
Participation in Joint Working Groups of the Three IVD industry
Organizations◆ Innovation Assessment for Clinical Laboratory Testing :(1) Challenge application(ii) Evaluation of usefulness and innovation◆ Rationalization of Insurance Application Examination◆ Appropriate Evaluation of tumor-related genetic testing◆ Contribution to AMR Measures◆ Evaluation of the POCT test

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With the cooperation of EBC for one year
Thank you very much.

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