EU approach to authorization of novel technologies …...International Symposium Alternatives to Antibiotics, 12 -15 December 2016 - Paris, France CVMP strategy on antimicrobials 2016

An agency of the European Union

EU approach to authorisation of novel technologies with particular emphasis on alternatives to antibiotics2nd International Symposium Alternatives to Antibiotics (ATA), 12-15 December 2016 Paris, France

Session 6 Regulatory Pathways to Enable the Licensing of Alternatives to Antibiotics and Issues and Opportunities from Funders’ Perspective

Presented by Dr Faye Ioannou on 15 December 2016 European Medicines Agency

Content of the presentation

• EU & CVMP antimicrobial resistance strategy with emphasis on alternatives to

antibiotics

• Available tools and pathways to facilitate authorisation of alternatives to antibiotics

in the EU

• Recent regulatory experiences, challenges and opportunities

• International cooperation

• Key messages

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Alternatives to antibiotics – A strategic priority in the EU (1)• The European Commission Action Plan on Antimicrobial Resistance adopted in

November 2011 recognizes the importance of developing new antimicrobials or alternatives to antibiotics in combating AMR

http://ec.europa.eu/dgs/health_consumer/docs/communication_amr_2011_748_en.pdf

Action n° 11: Reinforce and co-ordinate research efforts (including alternatives to antibiotics)

Action n° 12: Survey and comparative effectiveness research. Developing ATA is only one of many measures required for an effective plan to combat AMR.

• Many ongoing activities to implement above actions (e.g. HEALTH. 2013.2.3 1-1 on alternates to bacterial infections)

• New EC plan to be published in February 2017.

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Alternatives to antibiotics – A strategic priority in the EU (2)

• CVMP strategy on antimicrobials 2016-2020: adopted by CVMP on October 2016; laying the foundation for CVMP actions to combat AMR in next 5 years with clear reference to supporting development of alternatives to antibiotics*

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/10/WC500214901.pdf

• EMA and EFSA joint scientific opinion to EC on measures to reduce the need to use antimicrobial agents in animal husbandry in the European Union, and the resulting impacts on food safety (RONAFA), planned to be delivered in January 2017.

The report is to be divided into 3 main parts: Part 2 on possible alternatives to use of antimicrobials including specific measures on alternative therapies.

*CVMP is involved in the authorisation of veterinary medicinal products but not feed additives.

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CVMP Strategy on antimicrobials 2016-2020 (6 aims)

CVMP Strategy

Authorisation

Manage risk

Maintain existing

Develop new

Responsible use

International cooperation

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CVMP strategy on antimicrobials 2016-2020

“The CVMP will also support the development of veterinary medicines which reduce the need for use of antimicrobials (“alternatives”), such as vaccines, and will facilitate the regulatory pathway for innovative products by contributing guidance through the Innovation Task Force (ITF) and the CVMP Ad Hoc Group on Veterinary Novel Therapies (ADVENT)”

“..the CVMP recognises that AMR is an expanding global problem affecting both animal and human health. Therefore it is important that the CVMP continues to work with colleagues in the EU/EEA network agencies, international regulatory bodies and with its stakeholders to ensure harmonisation of regulatory frameworks and that a One Health approach is taken to the control of AMR”.

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CVMP strategy on antimicrobials 2016-2020 Aims relevant to alternatives (development and cooperation)

• Aim 4: To encourage and foster the development of alternatives to antimicrobials

• Aim 6: Work in partnership with EU/EEA and international human and animal health organisations to tackle the global problem of AMR

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CVMP strategy on antimicrobials 2016-2020 Aim 4The regulatory path for “novel” products including alternatives to antimicrobials is also supported through the Innovation Task Force and the CVMP’s ADVENT (Ad Hoc Expert Group on Veterinary Novel Therapies) group.

CVMP proposed actions: The CVMP wishes to contribute to a predictable regulatory environment that encourages investment…..and will:

reflect further on measures that could be taken to promote the development and access to market of alternatives to antimicrobials, giving particular attention to vaccines (novel and improved) as part of the current initiative to promote availability of products that can reduce the need for antimicrobial treatment within the EU.

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What are the available tools and pathways to facilitate authorisation of alternatives to antibiotics in the EU?

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Regulatory tools to facilitate authorisation of alternatives in the EU

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ADVENTGeneral advice-Not product specific

Pre-submission meetings Late developmentProduct specific

ADVENTGeneral guidance-Not product specific

Innovation Task Force (ITF)A multidisciplinary group that includes scientific, regulatory and legal competences:

• To establish a discussion platform for early dialogue with applicants to proactively identify scientific, legal and regulatory issues of emerging therapies and technologies

• To address the impact of emerging therapies and technologies on current scientific, legal and regulatory requirements with the Agency's committees and their working parties

• To identify the need for specialised expertise at an early stage

• To provide advice on the eligibility to Agency procedures relating to research and development, in conjunction with relevant EMA committees and other authorities

• To review the regulatory and scientific implications of emerging therapies and technologies, in conjunction with the Agency's committees and their working parties

• To increase awareness and learning in emerging therapies and technologies at the Agency.

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ITF briefing meetings• The ITF holds briefing meetings with applicants covering regulatory, technical and

scientific issues arising from the development of innovative medicines, new technologies and borderline products

• Free of charge

• Intended to facilitate the informal exchange of information and the provision of guidance early in the development process

• Within 60 days of receipt of a valid request from an applicant

• Experts from the Agency's network, working parties and committees, with the best available scientific expertise being represented

• Are intended to complement and reinforce existing formal regulatory procedures

• Briefing meeting request form to be sent to vetapplications@ema.europa.eu.

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Scientific Advice (CVMP SAWP-V)

• Scientific advice may be requested for all veterinary medicinal products (product related)

• A 60-90 days procedure after validation

• It can be requested for either centralised or de-centralised procedures

• Scientific advice mostly requested during the initial development of the veterinary medicinal product.

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Scientific Advice (CVMP SAWP-V)

• The question(s) should be as precise and clear and should address specific scientific issues concerning:

– Quality aspects

– Any safety aspect

– Clinical / efficacy aspects

– Establishment of maximum residue limits (MRLs)

– Contact EMA in advance of formal submission if you have questions about scope or

eligibility for SA.

Contact: vetscientificadvice@ema.europa.eu

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CVMP Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)• Provides guidance on the requirements for authorisation of novel veterinary medicines

• The advice will be general in nature and will not be related to a particular application or product

• The ADVENT’s tasks include:

– Providing advice on the requirements for authorisation of therapies that are new to the veterinary domain (novel therapies).

– Supporting dossier evaluation and referrals for novel therapies.

– International cooperation on novel therapy related issues.

– Advice, through the CVMP, to the European Commission.

– Contributing to novel therapy related workshops and training.

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ADVENT organisation

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CVMP

ADVENT core

group

Expert witness

ADVENT topic group

ADVENT topic groupADVENT

topic group

ADVENT topic group

Expert witness

Expert witness

Expert witness

CVMP Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)• Definition in the mandate of CVMP Ad Hoc Expert Group on Veterinary Novel Therapies:

Therapies that are entirely new to the veterinary domain, Represent a ‘first in class’, No experience within the veterinary regulatory community with respect to the therapy concerned

• ADVENT guidance is:

Advisory in nature, Not legally binding, General in nature and not related to a particular application, in the form of ‘Questions and Answers’, will be updated in line with subsequent scientific developments

• Stakeholders are invited and encouraged to submit their views on relevant novel therapy topics for which they consider guidance would be useful.

Contact: advent@ema.europa.eu

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Recent regulatory experiences, challenges and opportunities

• Regulatory challenges are not unique to ATA but are shared with all types of innovative technologies

• Workshops already initiated by EMA to provide assistance to industry on innovative types of alternatives i.e. Bacteriophage workshop in 2015

• Small number of ATA have been authorised centrally since last symposium and more requests for scientific advice on innovative ATA technologies have been received mainly on immunostimulants and vaccine products

• Scientific advice during development critical to success of the application; some needing more than one requests.

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Recent regulatory experiences, challenges and opportunities

• Products often combining traditional pharmaceutical and immunological properties; thus requiring: multi expertise assessment team, addressing a wide spectrum of parameters belonging to different categories of products, continuing and close cooperation between assessment team and applicant before and during authorisation process

• Challenges in establishing the clinical evidence of the reduction of antibiotic use claim (e.g. establishing quantifiable reduction claim, appropriate trial design)

• Benefit /Risk: The benefit of authorizing alternatives to antibiotics in the context of combating AMR cannot outweigh the lack of efficacy and/or safety.

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International cooperation

• Aim 6 on CVMP strategy on antimicrobials 2016-2020 recognizes the importance of international collaboration as important element in combating AMR and commits to increase cooperation and harmonisation of regulatory framework

• Parallel scientific advice with the FDA is established and open to applicants as an option• Active engagement with international cooperation initiatives with FDA, USDA, Health

Canada, Norway and other regulators e.g. TAFTAR (Trans-Atlantic Task Force on Antimicrobial Resistance) – recommendation 18

• EMA participating in implementing TAFTAR action plan for 2016-2020 that includes specific action on alternatives (Action 3.7): Veterinary regulatory agencies will discuss the particular challenges related to authorisation of novel veterinary therapies presented as alternatives to antimicrobials aiming to develop similar approaches and requirements, thereby accelerating access to market. CFIA, DG SANTE, EMA, FDA, HC, Norway, USDAhttp://www.cdc.gov/drugresistance/pdf/tatfar-report---recommendation-18.pdf

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Key messages

• EU regulators recognize the importance of stimulating the development of alternatives to antibiotics as part of combating AMR

• A number of regulatory initiatives included in CVMP strategy on antimicrobials 2016-2020 to encourage development of alternatives

• Strategic and early use of available tools to support innovation is critical in facilitating authorisation of alternatives in EU

• International cooperation between regulators is already established and there is commitment to increase collaboration in particular in developing a harmonized regulatory environment.

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Thank you for your attention

Dr Faye Ioannou - faye.ioannou@ema.europa.eu

European Medicines Agency30 Churchill Place • Canary Wharf • London E14 5EU • United KingdomTelephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555Send a question via our website www.ema.europa.eu/contact

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