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EUROPEAN COMMISSIONHEALTH AND CONSUMERS DIRECTORATE-GENERAL
Health Systems and ProductsMedicinal products authorisations,
EMA
Brussels,SANCO/RS/ar/ Sanco.ddg1.d.5(2012) 1783762
PUBLIC CONSULTATION PAPER
ON THE REGULATION ON ADVANCED THERAPY MEDICINAL PRODUCTS
Deadline for Public Consultation: 31 March 2013
This document does not represent an official position of the
European Commission. It is a tool to explore the views of
interested parties.
This document is to be read together with Regulation 1394/2007
of the European Parliament and of the Council on advanced therapy
medicinal products and amending Directive2001/83/EC
Contact:
European Commission, DG Health and Consumers, Unit D5 Medicinal
products authorisations,EMA
E-mail: [email protected]
http://ec.europa.eu/health/index_en.htm
mailto:[email protected]:[email protected]:[email protected]://ec.europa.eu/health/index_en.htmhttp://ec.europa.eu/health/index_en.htmmailto:[email protected]
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Table of contents
1. About the Consultation
................................................................................................
2
1.1. What is the purpose of this consultation?
....................................................................
2
1.2. Who is consulted?
........................................................................................................
2
1.3. How can I contribute?
..................................................................................................
2
1.4. What will happen
next?................................................................................................
2
2. Consultation topics
.......................................................................................................
2
2.1. Marketing authorisation application requirements for
advanced therapy medicinal products.
.......................................................................................................................
2
2.2. Requirements for combined advanced therapy medicinal
products. ........................... 3
2.3. Hospital exemption.
.....................................................................................................
3
2.4. Incentives for the development of advanced therapy
medicinal products. .................. 3
2.5. Scope and adaptation to technical progress.
................................................................
3
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1. ABOUT THE C ONSULTATION
1.1. What is the purpose of this consultation?
Regulation 1394/2007 of the European Parliament and of the
Council on advanced therapymedicinal products and amending
Directive 2001/83/EC (hereafter "Advanced Therapy
Regulation") requires the Commission to assess the application
of the Advanced TherapyRegulation and to produce a report.
With this public consultation, Directorate General for Health
and Consumers intends to seek the view of stakeholders regarding
the application of the Advanced Therapy Regulation.
Who is consulted?
All stakeholders with an interest in advanced therapy medicinal
products. Comments fromSmall and Medium-sized Enterprises (SMEs)
are particularly welcomed.
1.2. How can I contribute?
Contributions should be sent before 31 March 2013 by e-mail
exclusively to: [email protected]
When you submit your comments and responses, please state
whether you are an
association, a company, or a private individual. If you
represent an association, pleasedescribe the type of association (
e.g. patients, health professionals, industry). If you representa
company, please state whether it falls within the EU definition of
a small and medium-sizedenterprise. 1
Contributions will be made publicly available on the
Pharmaceuticals website of theCommission once the consultation
period is over, unless a specific request for confidentialityis
made, in which case only an indication of the contributor will be
disclosed. If you do notwish your contribution to be made public,
please clearly indicate so.
Professional organisations are invited to register in the Unions
Register of InterestRepresentatives (
http://europa.eu/transparency-register/index_en.htm ) set up as
part of theEuropean Transparency Initiative to provide the
Commission and the public at large withinformation about the
objectives, funding and structure of interest representatives.
1.3. What will happen next?
All contributions will be taken into consideration in the
preparation of the Commission reporton the application of the
Advanced Therapy Regulation.
1
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:124:0036:0041:EN:PDF
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:124:0036:0041:EN:PDFhttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:124:0036:0041:EN:PDFhttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:124:0036:0041:EN:PDFhttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:124:0036:0041:EN:PDFmailto:[email protected]:[email protected]
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2. C ONSULTATION TOPICS
2.1. Marketing authorisation application requirements for
advanced therapymedicinal products.
The Advanced Therapy Regulation provided for adapted
requirements in terms of the dossier
that applicants must prepare to demonstrate the quality,
efficacy and safety of the medicinal products when applying for a
marketing authorisation.
The amount of data that must be generated for the submission of
a marketing authorisationapplication is critical to ensure a high
level of public health protection. Proportionality of
therequirements is also important to facilitate the marketing of
advanced therapies.
Please provide your views on whether the requirements for
marketing authorisationapplications set out in the Regulation are
proportionate and adequate to ensure a high level of
public health.
2.2. Requirements for combined advanced therapy medicinal
products.
The existence of advanced therapy medicinal products that
incorporate one or more medicaldevices has been recognised and
regulated in the Advanced Therapy Regulation. In
particular, combined advanced therapy medicinal products are to
be authorised by theCommission following the scientific assessment
of the European Medicines Agency. Theapplicant must demonstrate
that the essential requirements of the specific legislation
onmedical devices have been complied with and there is a
possibility for the Agency to consultthe relevant notified
bodies.
No application for a combined advanced therapy medicinal product
has been submitted to theEuropean Medicines Agency yet.
Please provide your views on whether the procedure foreseen in
the Advanced TherapyRegulation to assess compliance with the
essential requirements of the medical devicelegislation is
adequate.
2.3. Hospital exemption.
The Advanced Therapy Regulation empowers Member States to
authorise the use of advanced therapy medicinal products in
hospitals for individual patients in the absence of amarketing
authorisation. The so-called hospital exemption provides for
flexibility to addressthe situation of medicinal products prepared
on a non-routine basis and used in a hospitalunder the exclusive
professional responsibility of a doctor for individual patients;
however, atoo large application of this exemption may discourage
the application for marketingauthorisations.
Please provide your views on the application of the hospital
exemption.
2.4. Incentives for the development of advanced therapy
medicinal products.
Advanced therapies are at the cutting edge of innovation. The
full development of the potential of this sector is closely linked
to the evolution of scientific knowledge. TheAdvanced Therapy
Regulation provides for a number of incentives to support the
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development of these products, such as certification for quality
and non-clinical data, reducedfees, scientific advice.
Please provide your views on the incentives provided for under
the Advanced TherapyRegulation.
2.5. Scope and adaptation to technical progress.The Advanced
Therapy Regulation applies to gene therapy medicinal products,
somatic celltherapy medicinal products and tissue engineered
products.
Please provide your views on the scope of the Regulation and in
particular as to whether thescope should be modified to take
account of technical progress.
