About this initiative

Public health
Type of act

Draft act

Feedback: closed

Draft regulation
More about draft acts

Feedback period
30 October 2017 - 27 November 2017
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Download (175.3 KB - PDF - 5 pages)

Feedback (9)

  • ISCT (United States)
    27 November 2017 Other
    ISCT (United States)

    ISCT appreciates the opportunity to submit comments on the EC DG Health and Food Safety’s draft regulation amending Regulation (EC) No 847/2000 regarding the definition of the concept 'similar medicinal product'. ISCT acknowledges the difficulty of defining the concept of similar medicinal product for ATMPs and considers the proposal reasonable. Nevertheless, we would also like to express our concern related to the ambiguity of the concepts ...

  • Anonymous (Spain)
    27 November 2017 Academic/research institution
    Anonymous (Spain)

    We fully endorse the suggestion made regarding the modification of Art 1 (3.2) of the Draft Regulation on the definition of the concept 'similar medicinal product' to read as follows: Gene therapy medicinal products: Two gene therapy medicinal products shall not be considered similar when there are differences in the therapeutic sequence, viral vector, transfer system, regulatory sequences or approaches for the delivery of the product to...

  • EFPIA-EuropaBio Joint Task Force on Orphan Medicinal Products and Rare Diseases (Belgium)
    27 November 2017 Business association
    EFPIA-EuropaBio Joint Task Force on Orphan Medicinal Products and Rare Diseases (Belgium)

    General comments Regulation 141/2000 (Orphan Regulation) and the accompanying Commission Regulation EC 847/2000 have successfully stimulated research and development of orphan medicinal products. The EFPIA-EuropaBio Joint Task Force would like to emphasise the vital importance of maintaining a favourable regulatory environment to continue to see progress in treating rare diseases. In order to have a consistent and transparent process, further...

All feedback (9) >

Commission adoption


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