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Scientific Recommendation on classification

By Gregory Ruiz,2014-10-29 20:49
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Scientific Recommendation on classification

    European Medicines Agency

    Scientific Recommendation on classification

    of Advanced Therapy Medicinal Products

    Request Form and Briefing Information

    Article 17 - Regulation (EC) No 1394/2007

The letter of intent (at least 1 month prior to the start of the procedure) and the request for scientific

    recommendation should be sent to AdvancedTherapies@emea.europa.eu (No fee required).

    Submission of scientific recommendation should follow the submission dates listing.

    Please send this form in Word format as it is. Do not convert it into PDF. Please note that all the fields followed by a red asterisk (*) are mandatory. If any of the mandatory fields is missing, the request will not be processed.

Information on the Request*

Company developing the product (applicant)

    Person authorised to communicate on behalf of

    the applicant 1Proposed product invented name or identifier

    Short descriptor (or name when available) of the 2proposed active substance

    Brief description of the proposed finished 3product

    Proposed indication

    Proposed advanced therapy medicinal product None Not combined

    classification

Proposed Summary for Public Release

Product description

    Therapeutic area

    Outcome of the scientific recommendation

    Date

    7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. +44 20 74 18 84 00 Fax +44 20 74 18 86 13 E-mail: CATsecretariat@emea.europa.eu http://www.emea.europa.eu European Medicines Agency, 2009. Reproduction is authorised provided the source is acknowledged

    The applicant presents hereafter its understanding of the regulatory definition of the product under development.

    The document addresses scientific, legal, regulatory and medical aspects supporting or not the applicability of the pharmaceutical framework for the development and evaluation of the product. The applicant discusses potentially overlapping aspects relevant to medical devices or cosmetics, human tissues and cells, blood products, borderline medical use or other issues as appropriate.

1. SCIENTIFIC ASPECTS

1.1. Active substance

    - Description of active substance (including starting materials, when relevant)*

    - Description of any additional substances (e.g. when applicable: structural component such

    as scaffolds, matrices, biomaterials, biomolecules and/or other components)

    - Description of medical device or active implantable medical device (when applicable)

1.2. Finished Product*

    - Qualitative & quantitative composition

    - Mode of Administration

    - Pharmaceutical form (use standard term as applicable) and description of the finished

    product ready for clinical use

1.3. Mechanism of Action / Proposed use*

    - Claimed mechanism of action

    - Properties (including pharmacological, immunological or metabolic, if applicable)

    - Proposed use / Indication (including therapeutic, prophylactic, diagnostic)

1.4. Summary of the status of the development of the product*

    - Key elements of manufacturing, quality aspects (including description and level of

    manipulations on cells and tissues, when applicable see Reg. 1394/2007, Annex I)

    - Outline of Non-Clinical development

    - Outline of Clinical development

     Note: specify the current stage of development.

……………………………………………………………………………………………………………

    …..

2. LEGAL AND REGULATORY ASPECTS

     42.1. Fulfilment of Article 1(2) of Directive 2001/83/EC (definition of medicinal product)*

2.2. Fulfilment of Article 2(1)(a-c) of Regulation (EC) No 1394/2007 (definition of advanced 5therapy medicinal product)*

    EMEA 2009 2/4

2.4. Fulfilment of Article 2(1)(d) of Regulation (EC) No 1394/2007 (definition of combined 6advanced therapy medicinal product)

     72.5. Fulfilment of Article 2(1) of Directive 2001/83/EC (products for human use intended to

    be placed on the market in Member States and either prepared industrially or

    manufactured by a method involving an industrial process), if applicable at the current

    stage of development

    2.6. Applicability/Inapplicability of any other potentially relevant EU legislation (e.g Dir.

    2004/23/EC on tissues and cells; Dir. 2002/98/EC on human blood and blood components;

    etc)

2.7. Other relevant aspects of European guidelines to be considered

……………………………………………………………………………………………………………

    …..

3. REGULATORY STATUS AND CURRENT MEDICAL USE

    3.1. Details of regulatory status (including medical (active implantable) device, when

    applicable) and marketing history in EU and non EU countries*

    Note: including copies of decisions or minutes with regulatory authorities (EU and non-EU).

3.2. Current medical use worldwide

……………………………………………………………………………………………………………

    …..

4. OTHER ASPECTS / BIBLIOGRAPHY

……………………………………………………………………………………………………………

    …..

5. CONCLUSIONS ON THE REGULATORY POSITIONING OF THE PRODUCT

……………………………………………………………………………………………………………

    …..

    EMEA 2009 3/4

     1 If an invented name is not available, use an adequate identifier (e.g. company internal code) followed by the Company name.

     2 The descriptor should identify the key identifying features of the active substance such as, depending on its nature, the gene to be transferred, vector, cells or tissues.

     3 Including, when applicable, devices/structural components being an integral part of the product.

     4 A medicinal product as defined in Article 1(2) of Directive 2001/83/EC, as amended, is: (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings;

    or

    (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis"

     5 Advanced therapy medicinal product‟ means any of the following medicinal products for human use:

    ; a gene therapy medicinal product as defined in Part IV of Annex I to Directive 2001/83/EC,

    ; a somatic cell therapy medicinal product as defined in Part IV of Annex I to Directive 2001/83/EC,

    ; a tissue engineered product, i.e. a product which contains or consists of engineered cells or tissues, and is presented as having properties for, or is used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue. A tissue engineered product may contain cells or tissues of human or animal origin, or both. The cells or tissues may be viable or non-viable. It may also contain additional substances, such as cellular products, bio-molecules, biomaterials, chemical substances, scaffolds or matrices. Products containing or consisting exclusively of non-viable human or animal cells and/or tissues, which do not contain any viable cells or tissues and which do not act principally by pharmacological, immunological or metabolic action, shall be excluded from this definition.

    Cells or tissues shall be considered „engineered‟ if they fulfill at least one of the following conditions:

    ; the cells or tissues have been subject to substantial manipulation, so that biological characteristics, physiological functions or structural properties relevant for the intended regeneration, repair or replacement are achieved. The manipulations listed in Annex I, in particular, shall not be considered as substantial manipulations,

    ; the cells or tissues are not intended to be used for the same essential function or functions in the recipient as in the donor.

    ; 6 Combined advanced therapy medicinal product‟ means an advanced therapy medicinal product that fulfils the

    following conditions:

    ; it must incorporate, as an integral part of the product, one or more medical devices within the meaning of Article 1(2)(a) of Directive 93/42/EEC or one or more active implantable medical devices within the meaning of Article 1(2)(c) of Directive 90/385/EEC, and

    ; its cellular or tissue part must contain viable cells or tissues,

    or

    ; its cellular or tissue part containing non-viable cells or tissues must be liable to act upon the human body with action that can be considered as primary to that of the devices referred to.

    ; 7 Article 2(1) of Directive 2001/83/EC provides that: “This directive shall apply to medicinal products for human

    use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.”

    EMEA 2009 4/4

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