{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T06:44:52Z","timestamp":1785739492189,"version":"3.56.0"},"reference-count":7,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T00:00:00Z","timestamp":1782432000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Regulation (EU) 2024\/1938 on Substances of Human Origin (SoHO), adopted in June 2024 and entering into application from 7 August 2027, establishes a unified and legally binding framework for all human-derived materials used in clinical practice, explicitly encompassing gametes and embryos. By replacing the previous EU Tissues and Cells Directives, it introduces harmonized standards for authorization, vigilance, and traceability, while reinforcing donor, recipient, and offspring protection. This commentary examines the main regulatory innovations relevant to medically assisted reproduction (MAR) and critically assesses their expected impact through a SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis. The SoHO Regulation offers an unprecedented opportunity to strengthen safety, quality, and ethical governance in MAR through evidence-based oversight and harmonized technical standards. However, its implementation may also generate significant administrative burden, challenges in proportionality, and potential delays in innovation. Overall, the SoHO Regulation represents a milestone for reproductive medicine, offering the chance to elevate safety and equity across Europe, provided its implementation is proportionate and supported by adequate guidance and collaboration among competent authorities and MAR professionals.<\/jats:p>","DOI":"10.1093\/humrep\/deag100","type":"journal-article","created":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T11:46:17Z","timestamp":1781178377000},"page":"1237-1244","source":"Crossref","is-referenced-by-count":0,"title":["A new regulatory framework: impact of the SoHO Regulation for medically assisted reproduction"],"prefix":"10.1093","volume":"41","author":[{"given":"Fiorenza","family":"Bariani","sequence":"first","affiliation":[{"name":"Italian National Transplant Centre, National Institute of Health , Rome,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3092-3546","authenticated-orcid":false,"given":"Alessandra","family":"Alteri","sequence":"additional","affiliation":[{"name":"Italian National Transplant Centre, National Institute of Health , Rome,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liliam","family":"Santilli","sequence":"additional","affiliation":[{"name":"Italian National Transplant Centre, National Institute of Health , Rome,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Teresa","family":"Vicentini","sequence":"additional","affiliation":[{"name":"Italian National Transplant Centre, National Institute of Health , Rome,","place":["Italy"]},{"name":"Eye Bank, San Salvatore Hospital , L\u2019Aquila,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paola","family":"Di Ciaccio","sequence":"additional","affiliation":[{"name":"Italian National Transplant Centre, National Institute of Health , Rome,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Letizia","family":"Lombardini","sequence":"additional","affiliation":[{"name":"Italian National Transplant Centre, National Institute of Health , Rome,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Feltrin","sequence":"additional","affiliation":[{"name":"Italian National Transplant Centre, National Institute of Health , Rome,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,6,26]]},"reference":[{"key":"2026080301512378900_deag100-B1","author":"European Centre for Disease Prevention and Control (ECDC)","year":"2025"},{"key":"2026080301512378900_deag100-B2","author":"European Commission","year":"2022"},{"key":"2026080301512378900_deag100-B3","author":"European Directorate for the Quality of Medicines & HealthCare (EDQM)"},{"key":"2026080301512378900_deag100-B4","first-page":"48","article-title":"Directive 2004\/23\/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells","volume":"L102","author":"European Parliament and Council of the European Union","year":"2004","journal-title":"Off J Eur Union"},{"key":"2026080301512378900_deag100-B5","first-page":"40","article-title":"Commission Directive 2006\/17\/EC of 8 February 2006 implementing Directive 2004\/23\/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells","volume":"L38","author":"European Parliament and Council of the European Union","year":"2006","journal-title":"Off J Eur Union"},{"key":"2026080301512378900_deag100-B6","first-page":"32","article-title":"Commission Directive 2006\/86\/EC of 24 October 2006 implementing Directive 2004\/23\/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells","volume":"L294","author":"European Parliament and Council of the European Union","year":"2006","journal-title":"Off J Eur Union"},{"key":"2026080301512378900_deag100-B7","first-page":"1","article-title":"Regulation (EU) 2024\/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002\/98\/EC and 2004\/23\/EC","volume":"L17.7.2024","author":"European Parliament and Council of the European Union","year":"2024","journal-title":"Off J Eur Union"}],"container-title":["Human Reproduction"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/humrep\/article-pdf\/41\/8\/1237\/68629818\/deag100.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/humrep\/article-pdf\/41\/8\/1237\/68629818\/deag100.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T05:51:26Z","timestamp":1785736286000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/humrep\/article\/41\/8\/1237\/8719237"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,26]]},"references-count":7,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2026,6,26]]},"published-print":{"date-parts":[[2026,8,1]]}},"URL":"https:\/\/doi.org\/10.1093\/humrep\/deag100","relation":{},"ISSN":["0268-1161","1460-2350"],"issn-type":[{"value":"0268-1161","type":"print"},{"value":"1460-2350","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,8]]},"published":{"date-parts":[[2026,6,26]]}}}