Challenges and ongoing initiatives towards better integrated EU scientific advice
Scientific advice is the main avenue for clarification of EU regulators’ scientific evidence requirements during medicines development. There are multiple avenues for seeking scientific advice in the EU with partially overlapping scope which creates room for divergence and contradictions; simplifica...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2025-01-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2025.1473346/full |
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| author | Iordanis Gravanis Michael Berntgen Spiros Vamvakas Pierre Demolis Paolo Foggi |
| author_facet | Iordanis Gravanis Michael Berntgen Spiros Vamvakas Pierre Demolis Paolo Foggi |
| author_sort | Iordanis Gravanis |
| collection | DOAJ |
| description | Scientific advice is the main avenue for clarification of EU regulators’ scientific evidence requirements during medicines development. There are multiple avenues for seeking scientific advice in the EU with partially overlapping scope which creates room for divergence and contradictions; simplification and better integration among them could help harmonize EU regulators’ requirements. Interaction with other decision makers providing advice along the lifecycle of medicines and other healthcare solutions reduces development uncertainties. The proposal for a new EU pharmaceutical legislation solidifies existing advice mechanisms and creates new avenues for enhanced integration of development support. |
| format | Article |
| id | doaj-art-b2b1ac47e54643579629a07cb612994e |
| institution | Kabale University |
| issn | 2296-858X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj-art-b2b1ac47e54643579629a07cb612994e2025-01-27T06:40:55ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2025-01-011210.3389/fmed.2025.14733461473346Challenges and ongoing initiatives towards better integrated EU scientific adviceIordanis Gravanis0Michael Berntgen1Spiros Vamvakas2Pierre Demolis3Paolo Foggi4European Medicines Agency, Amsterdam, NetherlandsEuropean Medicines Agency, Amsterdam, NetherlandsEuropean Medicines Agency, Amsterdam, NetherlandsLyfjastofnun-Icelandic Medicines Agency, Reykjavík, IcelandAgenzia Italiana del Farmaco - Italian Medicines Agency, Rome, ItalyScientific advice is the main avenue for clarification of EU regulators’ scientific evidence requirements during medicines development. There are multiple avenues for seeking scientific advice in the EU with partially overlapping scope which creates room for divergence and contradictions; simplification and better integration among them could help harmonize EU regulators’ requirements. Interaction with other decision makers providing advice along the lifecycle of medicines and other healthcare solutions reduces development uncertainties. The proposal for a new EU pharmaceutical legislation solidifies existing advice mechanisms and creates new avenues for enhanced integration of development support.https://www.frontiersin.org/articles/10.3389/fmed.2025.1473346/fullResearch and Development (R&D)scientific adviceclinical trialsmedical devicesinnovative combination productshealth technology assessment |
| spellingShingle | Iordanis Gravanis Michael Berntgen Spiros Vamvakas Pierre Demolis Paolo Foggi Challenges and ongoing initiatives towards better integrated EU scientific advice Frontiers in Medicine Research and Development (R&D) scientific advice clinical trials medical devices innovative combination products health technology assessment |
| title | Challenges and ongoing initiatives towards better integrated EU scientific advice |
| title_full | Challenges and ongoing initiatives towards better integrated EU scientific advice |
| title_fullStr | Challenges and ongoing initiatives towards better integrated EU scientific advice |
| title_full_unstemmed | Challenges and ongoing initiatives towards better integrated EU scientific advice |
| title_short | Challenges and ongoing initiatives towards better integrated EU scientific advice |
| title_sort | challenges and ongoing initiatives towards better integrated eu scientific advice |
| topic | Research and Development (R&D) scientific advice clinical trials medical devices innovative combination products health technology assessment |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2025.1473346/full |
| work_keys_str_mv | AT iordanisgravanis challengesandongoinginitiativestowardsbetterintegratedeuscientificadvice AT michaelberntgen challengesandongoinginitiativestowardsbetterintegratedeuscientificadvice AT spirosvamvakas challengesandongoinginitiativestowardsbetterintegratedeuscientificadvice AT pierredemolis challengesandongoinginitiativestowardsbetterintegratedeuscientificadvice AT paolofoggi challengesandongoinginitiativestowardsbetterintegratedeuscientificadvice |