Regulating advanced therapy medicinal products through the Hospital Exemption: an analysis of regulatory approaches in nine EU countries
Research output: Contribution to journal › Journal article › Research › peer-review
Aim: To study regulatory approaches for the implementation and utilization of the Hospital Exemption (HE) in nine EU countries. Materials & methods: Using public regulatory documentation and interviews with authorities we characterized the national implementation process of the HE, including national implementation characteristics and two outcomes: national licensing provisions and the amount of license holders. Results: National licensing provisions vary substantially among selected countries as a result of different regulatory considerations that relate to unmet medical needs, benefit/risk balance, and innovation. The amount of license holders per country is moderate (0-11). Conclusion: The HE facilitates HE utilization in clinical practice in some countries, yet safeguarding of public health and incentivizing commercial development is challenging.
Original language | English |
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Journal | Regenerative Medicine |
Volume | 15 |
Issue number | 8 |
Pages (from-to) | 2015-2028 |
Number of pages | 14 |
ISSN | 1746-0751 |
DOIs | |
Publication status | Published - Aug 2020 |
- advanced therapy medicinal product, clinical practice, commercial development, drug regulatory science, hospital exemption, implementation process, license holders, national licensing provisions, REGENERATIVE MEDICINE, EUROPEAN-UNION, MEMBER STATES, CELL, LEGISLATION, CHALLENGES, TRANSPOSITION, ADOPTION, FUTURE, ACCESS
Research areas
ID: 271639616