12 April 2017 EMA/699038/2016 Inspections, Human Medicines Pharmacovigilance & Committees

CAT work plan 2017 – adopted by the Committee on 12 April 2017

Table of Content 1. Evaluation activities for human medicines .............................................. 2 1.1. Pre-authorisation activities .................................................................................... 2 1.2. Initial-evaluation activities ..................................................................................... 4 1.3. Other specialised areas and activities ...................................................................... 6

2. Horizontal activities and other areas ..................................................... 10 2.1. Committees and working parties .......................................................................... 10

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

1. Evaluation activities for human medicines 1.1. Pre-authorisation activities 1.1.1. Revision of ATMP specific guidelines Key objectives •

Revision of the Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells.

Activities in 2017 – 2019 CAT activities to achieve the objectives set for this area: •

Finalise a concept paper on the revision of the above mentioned guideline, to be published by end of 3Q 2017



Publication of the draft of the revised Guideline for external consultation by 1Q 2018



Finalise the Revision of the Guideline by 4Q 2018

CAT will collaborate with the BWP for the revision of the quality part of this guideline. CAT topic leader: Marcos Timón Other Committee participants: Member/alternate

Name

MS

CAT topic leader

Marcos Timon

Spain

Member

Ilona Reischl

Austria

Member

Paula Salmikangas

Finland

Member

Christiane Niederlaender Belaid Sekkali

UK

Portugal

Expert

Margarida Menezes Ferreira Tiina Palomäki

Expert

Guido Pantè

Italy

Expert

Matthias Renner

Germany (PEI)

Expert

Brigitte Anliker

Germany (PEI)

Expert

Nicoloas Anagnou

Greece

Alternate Alternate

CAT work plan 2017 EMA/699038/2016

Belgium

Finland

Page 2/10

1.1.2. Development of ATMP specific guidelines Key objectives •

Development of a guideline on comparability of cell-based medicinal products

Activities in 2017-2019 CAT activities to achieve the objectives set for this area: •

Finalise a concept paper on the above mentioned guideline, to be published by end 4Q 2017



Publication of the draft of the Guideline for external consultation by 4Q 2018



Finalise the Guideline in 2019

CAT will collaborate with the BWP for the development of the quality part of this guideline. CAT topic leader: Margarida Menezes-Ferreira / Ilona Reischl Other Committee participants: Member/alternate

Name

MS

CAT topic leader

Margarida Menezes-Ferreira

Portugal

CAT topic leader

Ilona Reischl

Austria

Member

Violaine Closson Carella

France

Member

Paula Salmikangas

Finland

Member

Maura O’Donovan

Ireland

Member

Tomáš Boráň

Czech Republic

Member

Marc Turner

Member

Bernd Gänsbacher

Alternate

Belaid Sekkali

Scottish National Blood Transfusion Service Institute of experimental oncology and therapeutics Belgium

Alternate

Ivana Haunerova

Czech Republic

Expert

Tiina Palomäki

Finland

Expert

Louise Bisset

UK

Expert

Thomas Hinz

Germany (PEI)

CAT work plan 2017 EMA/699038/2016

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1.2. Initial-evaluation activities 1.2.1. Reflection on the Benefit Risk assessment of ATMPs During the multi-stakeholder meeting of 27 May 2016 on Advanced therapy medicinal products, stakeholders noted that current practice of defining the benefit-risk balance focuses mainly on risks and called for additional emphasis to be placed on expected but realistic benefits, particularly where patients have incurable diseases or where suitable treatments are lacking. CAT will reflect how this observation can be taken into account during the benefit-risk assessment that forms the basis of the approval of a marketing authorisation for ATMPs.

Key objectives •

Reflection on the Benefit-Risk assessment of ATMPs

Activities in 2017 CAT activities to achieve the objectives set for this area: •

Hold a meeting with the CAT interested parties to initiate the reflection on benefit-risk criteria specific to ATMPs. Deadline: 4Q 2017



Based on the outcome of the interested parties’ meeting, discuss the possibility and need to develop a CAT discussion paper on benefit-risk assessment of ATMPs. Deadline: 4Q 2017



If the development of a discussion paper on the benefit-risk assessment of ATMPs is decided, include this topic as a formal CAT activity in CAT work plan for 2018. CAT will collaborate with the CHMP, PRAC, PCWP and HCPWP for the development of this discussion paper.

CAT topic leader: Martina Schüßler-Lenz Other Committee participants: Member/alternate

Name

MS

CAT topic leader

Martina Schüßler-Lenz

Germany

Member

Claire Beuneu

Belgium

Member

Kieran Breen

Member

Maura O’Donovan

European Parkison’s Disease Association Ireland

Member

Bernd Gänsbacher

Member

Marc Turner

Alternate

Erik Briers

Alternate

Michelino Lipucci di Paola

CAT work plan 2017 EMA/699038/2016

Institute of experimental oncology and therapeutics Scottish National Blood Transfusion Service Europa Uomo – The European Prostate Cancer Coalition European Organisation for Rare Diseases (Eurordis)

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1.2.2. Reflection on the use of Registry data for the initial evaluation of ATMPs and during the post-authorisation phase. Key objectives •

CAT reflection on the use of registry data for the approval and post-marketing follow-up of ATMPs

Activities in 2017 CAT activities to achieve the objectives set for this area: •

Hold a meeting with the CAT interested parties to initiate the reflection on the use of registry data for the approval and post-marketing follow-up of ATMPs. Deadline: 4Q 2017



Based on the outcome of the interested parties’ meeting, discuss the possibility and need to develop a CAT discussion paper on the use of registry data for the approval and post-marketing follow-up of ATMPs. Deadline: 4Q 2017



If the development of a discussion paper on the above is decided, include this topic as a formal CAT activity in CAT work plan for 2018. CAT will collaborate with the CHMP for the development of this discussion paper.

CAT topic leader: Kieran Breen Other Committee participants: Member/alternate

Name

MS

CAT topic leader

Kieran Breen

Member

Tomáš Boráň

European Parkinson’s Disease Association Czech Republic

Member

Simona Badoi

Romania

Member

Marc Turner

Member

Mariette Driessens

Alternate

Erik Briers

Alternate

Michele Lipucci

Scottish National Blood Transfusion Service European Genetic Alliances Network (EGAN) Europa Uomo – The European Prostate Cancer Coalition Eurordis

Alternate

Angeliki Roboti

Greece

Expert

Klaus Rensing

Germany (PEI)

CAT work plan 2017 EMA/699038/2016

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1.3. Other specialised areas and activities 1.3.1. Scientific and Regulatory considerations on gene editing technologies Key objectives •

Reflection on the regulatory status of medicines based on, or produced by means of gene editing technologies



Consideration of the scientific requirements of medicines based on, or produced by means of gene editing technologies

Activities in 2017-2018 CAT activities to achieve the objectives set for this area: •

Discussion on the regulatory status of medicines based on, or produced by means of gene editing technologies. Deadline: 3Q 2017



Develop a CAT document on the regulatory considerations of this new technology (for use within the EU network). Deadline 4Q 2017



Organise an expert meeting to discuss with developers / experts in the field scientific challenges of this new technology, with the involvement of members from the Biologics Working Party (BWP) and the Pharmacogenomic Working Party (PGWP). Deadline 4Q 2017



Prepare a meeting report, publication or CAT document on regulatory and scientific considerations related to the development of medicines based on or produced by means of gene editing technologies. Deadline: 3Q 2018.

CAT topic leader: Paolo Gasparini Other Committee participants: Member/alternate

Name

MS

CAT topic leader

Paolo Gasparini

Italy

Member

Toivo Maimet

Estonia

Member

Paula Salmikangas

Finland

Member

Asterios Tsiftsoglou

Greece

Member

Maura O’Donovan

Ireland

Member

Dariusz Sladowski

Poland

Member

Simona Badoi

Romania

Member

Metoda Lipnik-Stangelj

Slovenia

Member

UK

Member

Christiane Niederlaender Bernd Gänsbacher

Alternate

Belaid Sekkali

Alternate

Portugal

Alternate

Margarida MenezesFerreira Egbert Flory

Alternate

Rune Kjeken

Norway

Alternate

Marcos Timon

Spain

Alternate

Michele Lipucci

Eurodis

CAT work plan 2017 EMA/699038/2016

Institute of experimental oncology and therapeutics Belgium

Germany

Page 6/10

Member/alternate

Name

MS

Expert

Tiina Palomäki

Finland

Expert

Silke Schuele

Germany (PEI)

CAT work plan 2017 EMA/699038/2016

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1.3.2. Considerations on novel scientific and regulatory approaches for making ATMPs more readily available to patients Key objectives •

Reflection and horizon scanning on novel approaches to make ATMPs more readily available to patients, such as the use of adeno-associated viral vectors

Activities in 2017 CAT activities to achieve the objectives set for this area: •

A CAT subgroup will initiate discussion and prepare a draft document with examples of such approaches and challenges related to them, for discussion in the CAT plenary meeting or during a CAT Strategic Review and Learning meeting. Deadline: 4Q 2017



Identify issues that require further reflection and plan ahead for activities to be explored in the CAT 2018 Work Plan. CAT will collaborate with the BWP and the HMA innovation network on this topic. Deadline: 4Q 2017.



Organisation of an expert meeting on scientific consideration for adeno-associated vector (AAV) based GTMPs. Deadline: 4Q 2017.

CAT topic leader: Hans Ovelgönne / Rune Kjeken Other Committee participants: Member/alternate

Name

MS

CAT topic leader

Hans Ovelgönne

Netherlands

CAT topic leader

Rune Kjeken

Norway

Member

Paula Salmikangas

Finland

Member

Toivo Maimets

Estonia

Member

Paolo Gasparini

Italy

Member

Simona Badoi

Romania

Member

Metoda Lipnik-Stangelj

Slovenia

Member

Christiane Niederlaender

UK

Member

Bernd Gänsbacher

Member

Marc Turner

Alternate

Margarida Menezes-Ferreira

Institute of experimental oncology and therapeutics Scottish National Blood Transfusion Service Portugal

Alternate

Ivana Haunerova

Czech Republic

Alternate

Angeliki Roboti

Greece

CAT work plan 2017 EMA/699038/2016

Page 8/10

1.3.3. Addressing the Environmental Risk assessment of ATMPs containing genetically modified organisms (GMO) / genetically modified microorganisms (GMM). Key objectives •

Contribute to the European Commission in support of the discussions on GMO related issues in the ad-hoc group of national experts on medicines and experts from the environmental authorities.

Activities in 2017-2018 CAT activities to achieve the objectives set for this area: •

Provide technical and scientific input to the Commission. Deadline: 2Q 2018

CAT topic leader: Ilona Reischl Other Committee participants: Member/alternate

Name

MS

CAT topic leader

Ilona Reischl

Austria

Member

Paula Salmikangas

Finland

Member

Claire Beuneu

Belgium

Member

Violaine Closson Carella

France

Member

Krisztian Fodor

Hungary

Member

Dariusz Sladowski

Poland

Alternate

Margarida Menezes Ferreira

Portugal

Alternate

Marcos Timon

Spain

Alternate

Erik Briers

Europa Uomo - The European Prostate Cancer Coalition

CAT work plan 2017 EMA/699038/2016

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2. Horizontal activities and other areas 2.1. Committees and working parties 2.1.1. Setting up of an Ad hoc COMP-CAT working group Key objectives •

Explore the possibility to set up and define the activities of an Ad hoc COMP-CAT working group

Activities in 2017 CAT activities to achieve the objectives set for this area: •

Initiate discussion with COMP colleagues on areas for collaboration between COMP and CAT on orphan ATMPs. Deadline 3Q 2017



Discuss in CAT and COMP the possibility to set up an Ad hoc working group as a format to facilitate the interaction between the two Committees. Deadline 4Q 2017

CAT topic leader: Simona Badoi Other Committee participants: Member/alternate

Name

MS

CAT topic leader

Simona Badoi

Romania

Member

Mariëtte Driessens

Member

Kieran Breen

Expert

Guido Pantè

European Genetic Alliances Network (EGAN) European Parkinson's Disease Association Italy

CAT work plan 2017 EMA/699038/2016

Page 10/10

CAT work plan 2017 - European Medicines Agency - Europa EU

Apr 12, 2017 - Member. Marc Turner. Scottish National Blood Transfusion. Service .... CAT will collaborate with the BWP and the HMA innovation network on this ... 1.3.3. Addressing the Environmental Risk assessment of ATMPs containing.

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