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Consultation on IMI Advanced Therapies Concept Paper


Update of 15 September 2016: The outcomes of the consultation have now been published.

Update of 26 July 2016: the consultation is now closed. Thank you to all organisations and individuals who contributed their comments and ideas. IMI will now analyse the contributions and use them to design a second workshop which will be held during IMI's Stakeholder Forum on 29 September 2016 in Brussels, Belgium.

The field of advanced therapy medicinal products (ATMP) is scientifically progressing at a very fast pace, as demonstrated by the number and variety of clinical trials conducted over the last five years, yet there are numerous factors that have complicated the translation from research into patient access.

IMI, in collaboration with key stakeholders, has developed a concept paper on advanced therapies which we are posting for public consultation. The aim of the concept paper is to identify the potential of IMI as a platform for enhancing ATMP research and development. The European Union needs to ensure that these advances are translated into realities for patients as soon as possible while contributing to making Europe’s industry more competitive in this new field. 

Contributors who wish to submit comments on the concept paper are encouraged to consider in particular the following questions:

  •  Have the key challenges that can be addressed through collaborative, public-private initiatives been properly identified?
  •  Which of the proposed potential initiatives should be prioritised?
  •  Are any areas missing?
  •  What are the key European or national initiatives that IMI shall synergise with?


Deadline for submitting comments: 25 July 2016

Target Group

All citizens and organisations are welcome to contribute to this consultation. Contributions are particularly sought from research organisations, universities, public authorities, industry, small or medium-sized enterprises and non-governmental organisations.

How to submit your contribution

Comments on the concept paper should be addressed by e-mail to consultations[AT] or through the appropriate State Representative Group member.

When sending comments, please give us your name and organisation and state clearly if you are sending comments in a personal capacity or on behalf of an organisation.

For the purposes of transparency and to encourage debate, all contributions received will be published on the IMI website along with the name, organisation and country of the contributor, unless respondents explicitly provide a reasoned opposition to the publication of either their contribution or their personal details. 

Personal data will be treated in accordance with the terms of Regulation (EC) No 45/2001. Questions related to personal data should be addressed by e-mail through Data-Protection[AT]

Results of consultation and next steps

On the basis of the input received, IMI will organise a second workshop in late 2016 that will draw conclusions from and conclude the consultation. These conclusions will inform the development of an IMI ATMP portfolio of projects that could be launched from 2017 onwards.