SHARE-SoHO

supporting Health Authorities on the new Regulation

SHARE-SoHO (HaDEA/2024/OP/0057) is a service designed to support National and Competent Authorities across EU Member States and EEA countries in implementing Regulation (EU) 2024/1938 on Substances of Human Origin (SoHO), which enters into application from August 2027.
The Regulation replaces the former Directives 2002/98/EC and 2004/23/EC, extending its scope to all substances of human origin intended for human application and introducing more stringent requirements for donor and recipient protection, vigilance and supply continuity.

The Consortium

The service is delivered by a Consortium led by KPMG, together with the Joint Tenderers – the Italian National Blood and Transplant Centres (Centro Nazionale Sangue – CNS, Centro Nazionale Trapianti – CNT) of the National Institute of Health (Istituto Superiore di Sanità – ISS), Zadig and Open Evidence – and in collaboration with a team of external experts, on behalf of the European Health and Digital Executive Agency (HaDEA) and the European Commission (DG SANTE).

To read more about the Consortium, click here.

The pillars of the project

The aim of this service is to provide SoHO National Authorities (SNAs) and SoHO Competent Authorities (SCAs) with a structured pathway of assessment, guidance and training, conceived as a supportive tool.
The pillars of the project are:

Mapping and analysis: a shared, confidential overview of the current state of implementation of the Regulation in each country, developed in collaboration with the Authorities themselves.
Tailored action plans: concrete organisational and legal recommendations, calibrated to the specific circumstances of each Authority.
Training and capacity building: a comprehensive programme of training sessions, peer exchanges and practical tools, designed to strengthen staff competences on a lasting basis.

The phases of the project

The SHARE-SoHO pathway unfolds across six phases (Tasks), conceived as a logical sequence but with functional overlaps to accelerate results:

Mapping the status quo — Identification and validation, in collaboration with the SoHO Coordination Board and national Ministries of Health, of the SoHO National and Competent Authorities in each country, followed by a structured survey (conducted using deliberately non-evaluative terminology, to reflect the collaborative nature of the exercise) into the organisational, legal and operational status of each Authority.
Gap analysis — A comparison between the current situation and an "ideal state" defined on the basis of the Regulation and guidance from bodies such as EDQM and ECDC, resulting in 30 country fiches (27 Member States and 3 EEA countries) containing practical, confidential recommendations.
Action plans and training plans — Development of individual plans for each Authority, covering organisational set-up, national legal adjustments, communication strategy, human resources development and monitoring indicators, accompanied by equally tailored training plans.
Delivery of national training — The implementation phase in which plans are translated into concrete training sessions and capacity-building activities, described in further detail below.
EU-level training plan — Consolidation of the common training needs identified at national level into a modular European programme, validated through a co-design process with the SoHO Coordination Board.
EU training programme and closure — European training sessions, exchange visits between Authorities and a concluding workshop in Brussels, crowning the capacity-building pathway launched under the project.

Training at the heart of the project

SHARE-SoHO dedicates a substantial share of its activities to the direct training of SNA/SCA staff, with an overall commitment to reach at least 200 staff members at national level, complemented by further sessions at European level, amounting to dozens of training events, bilateral exchanges and cross-country dialogue opportunities.
Training activities are designed to be practical, modular and accessible, structured to respond to the specific needs identified through the assessment carried out for each Authority.
Training is the distinguishing feature of SHARE-SoHO, translating the findings of the earlier analytical phases into concrete competences. The programme is built on two complementary levels.

At national level, each Member State receives:

a training session lasting three days, structured around theoretical modules, case studies, role-based activities, etc.;
a targeted capacity-building exchange lasting one full day, based on a twinning model between Authorities at different levels of regulatory maturity, to encourage direct peer-to-peer knowledge transfer.

At EU level, the programme continues and is further enriched through:

three EU-level training sessions, each lasting two days, bringing together groups of Member States with similar regulatory characteristics, structured around broader themes (e.g. authorisation, legal frameworks, risk-based inspection) and more technical topics (e.g. traceability, vigilance, emergency preparedness);
27 exchange visits lasting two days each, enabling representatives from different Authorities to observe first-hand the operational workflows, inspection procedures and vigilance systems of their counterparts;
a concluding workshop in Brussels, bringing together at least one representative from each Member State and EEA country to share results, good practice and future prospects for cooperation.

The SHARE-SoHO platform

This platform has been developed to accompany you throughout the SHARE-SoHO training programme. Here you will find access to learning materials and modules relevant to your Authority, guidance documents and practical tools, as well as post-training assessments and satisfaction surveys.
The platform will also host a discussion forum, enabling professionals from different SNAs and SCAs to exchange experiences, reference materials and common challenges throughout the duration of the service and beyond.