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 Reaching for new medical frontiers with emerging cell & tissue engineered products
Tissue engineering is a fast developing area in human healthcare. Rapid but also strategic action regarding new policies and regulations is crucial for the development of this field in which a large amount of high-level research is currently ongoing in Europe. Moreover, a market survey performed by IPTS, the EU Commission’s Institute for Prospective Technology Studies, has shown that this field has high potential in regenerative medicine and for unmet medical needs such as cartilage replacement, and regeneration of necrosed tissues.
Therefore, in 2002 the Commission launched a public consultation to assess the need for a legislative framework for human tissue engineering and tissue-engineered products.
The Commission consultation has resulted in consensus, in particular among industry and Member States, in favour of a specific and uniform EU regulatory framework covering cell- and tissue-engineered products.
Since the beginning, EuropaBio has been advocating for a new and harmonized legislative framework to address the regulatory needs of tissue engineered products in a comprehensive manner. These products require specific rules for clinical trials and manufacturing and would benefit from a centralised approval system based on expert evaluation.
This regulatory framework should aim to ensure the highest level of safety for patients while also ensuring the free movement of tissue-engineered products within the Community, and easy access to these products for patients in need. EuropaBio has been engaged in constructive dialogue with the Commission and other stakeholders to create the necessary conditions for the development of these new, innovative products and to offer new treatment opportunities for patients.
EuropaBio Actions
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Coordination of effective industry advocacy to ensure the approval of European regulation for advanced therapies.
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Input into EMEA’s consideration of assessment processes for gene therapies.
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Educational campaign targeting general public and decision makers on the societal benefits of a balanced regulation of advanced therapies.
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