Kiri

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

The Director-General

Brussels SANTE.D.2/SVDS/EB/(2025)11080014

Dear Director-General,

I am writing to you regarding the implementation of the EU Substances of Human Origin

(SoHO) Regulation (EU/2024/1938). This Regulation will ensure citizens’ future access

to essential and qualitative blood, tissue and cell therapies.

More than a year has passed since adoption of the Regulation, and we now have less than

two years remaining before full date of application on 7 August 2027.

We would like to thank you for all the efforts that went already into the implementation of

this new legislation in your country. This first year after adoption has allowed for a strong

start in our joint preparations.

The SoHO Coordination Board (SCB) has been established, along with six working

groups, to develop a common understanding and practical guidance for the implementation

of the new framework, in a harmonised way across the EU. A first implementing act has

been adopted concerning the new digital platform and the joint development of the first

digital modules (focused on registration and assessing innovations) is progressing well. All

Member States have now nominated participants in the SCB and to most of the six working

groups, allowing us to build on input and experience from national administrations and

healthcare services. We are extremely grateful for the work your representatives perform

in the SCB and its working groups.

Looking ahead, it is important to keep up this positive momentum and to deliver on our

commitments in due time. For this, it will be crucial to ensure an effective coordination

and communication between your different experts and representatives at national level.

Furthermore, my services will continue to strengthen the coordination of the work between

SoHO Expert Bodies, namely the European Centre for Disease Prevention and Control

(ECDC) and the European Directorate on the Quality of Medicines and Healthcare

(EDQM), where your national experts also play a key role.

During this second year, additional implementing legal acts will be adopted, and the

development of the EU SoHO platform will progress. Moreover, work on compensating

living donors and maximum offspring of living donors will be developed. For all these

tasks we continue to count on the input of your national authorities and healthcare services,

through the SCB.

2

I also want to take this occasion to recall the need for alignment of your national legislation

with the new SoHO Regulation, particularly national legislation transposing the current

Directives on blood (2002/98/EC) and on tissues and cells (2004/23/EC) whose provisions

will cease to apply as of August 2027. Furthermore, in many Member States national

legislation includes other elements complementary to the EU framework, such as rules on

consent or funding, which may also require alignment with the new SoHO Regulation.

Amongst the first preparatory steps, it will be essential to designate an autonomous SoHO

national authority, and further SoHO competent authorities as needed (as per Article 5),

and to prepare for a communication strategy or other means to raise awareness towards the

SoHO professionals in your Member State.

Biotechnology is a rapidly evolving sector, and the future SoHO framework must therefore

interact smoothly with other frameworks, such as those for pharmaceuticals, medical

devices and information/communication technologies. Several upcoming initiatives,

through the SCB and through EU4Health funding, will therefore require coordinated input

from your experts in all these frameworks. It will be essential for future European

biotechnology to develop clear and coherent frameworks, and I count on your support to

strengthen this collaboration at EU and national level.

Finally, I would like to draw your attention to the opportunities for support to your national

authorities provided through EU4Health initiatives, in particular the SHARE-SoHO action

which has just started. This action will offer expertise and advice to the national authorities

when preparing for the new SoHO Regulation by summer 2027, including a gap-analyses,

national action plan, training and exchange of know-how.

Do not hesitate to come back to my colleagues in the SoHO team, via SoHO-

[email protected] in case you have further questions or would appreciate a

discussion.

I look forward to continuing the good collaboration.

Yours faithfully,

Sandra GALLINA

cc.: BOIX ALONSO Lorena (SANTE.DDG1), BECKER Rainer (SANTE.D),

MATHIEU-MENDES Agnes (SANTE.D.2), MCGEEHAN Richard (SANTE),

BATTISTINI Luca (SANTE), MOYA DIAZ Marta (SANTE.A.2), VAN DER SPIEGEL

Stefaan (SANTE.D.2), BAERT Katleen (SANTE.D.2), MARCHAND Els (SANTE.D.2),

CICCARELLO Martina (SANTE.A.2)

Electronically signed on 08/12/2025 23:54 (UTC+01) in accordance with Article 11 of Commission Decision (EU) 2021/2121

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

The Director-General

Brussels SANTE.D.2/SVDS/EB/(2025)11080014

Dear Director-General,

I am writing to you regarding the implementation of the EU Substances of Human Origin

(SoHO) Regulation (EU/2024/1938). This Regulation will ensure citizens’ future access

to essential and qualitative blood, tissue and cell therapies.

More than a year has passed since adoption of the Regulation, and we now have less than

two years remaining before full date of application on 7 August 2027.

We would like to thank you for all the efforts that went already into the implementation of

this new legislation in your country. This first year after adoption has allowed for a strong

start in our joint preparations.

The SoHO Coordination Board (SCB) has been established, along with six working

groups, to develop a common understanding and practical guidance for the implementation

of the new framework, in a harmonised way across the EU. A first implementing act has

been adopted concerning the new digital platform and the joint development of the first

digital modules (focused on registration and assessing innovations) is progressing well. All

Member States have now nominated participants in the SCB and to most of the six working

groups, allowing us to build on input and experience from national administrations and

healthcare services. We are extremely grateful for the work your representatives perform

in the SCB and its working groups.

Looking ahead, it is important to keep up this positive momentum and to deliver on our

commitments in due time. For this, it will be crucial to ensure an effective coordination

and communication between your different experts and representatives at national level.

Furthermore, my services will continue to strengthen the coordination of the work between

SoHO Expert Bodies, namely the European Centre for Disease Prevention and Control

(ECDC) and the European Directorate on the Quality of Medicines and Healthcare

(EDQM), where your national experts also play a key role.

During this second year, additional implementing legal acts will be adopted, and the

development of the EU SoHO platform will progress. Moreover, work on compensating

living donors and maximum offspring of living donors will be developed. For all these

tasks we continue to count on the input of your national authorities and healthcare services,

through the SCB.

2

I also want to take this occasion to recall the need for alignment of your national legislation

with the new SoHO Regulation, particularly national legislation transposing the current

Directives on blood (2002/98/EC) and on tissues and cells (2004/23/EC) whose provisions

will cease to apply as of August 2027. Furthermore, in many Member States national

legislation includes other elements complementary to the EU framework, such as rules on

consent or funding, which may also require alignment with the new SoHO Regulation.

Amongst the first preparatory steps, it will be essential to designate an autonomous SoHO

national authority, and further SoHO competent authorities as needed (as per Article 5),

and to prepare for a communication strategy or other means to raise awareness towards the

SoHO professionals in your Member State.

Biotechnology is a rapidly evolving sector, and the future SoHO framework must therefore

interact smoothly with other frameworks, such as those for pharmaceuticals, medical

devices and information/communication technologies. Several upcoming initiatives,

through the SCB and through EU4Health funding, will therefore require coordinated input

from your experts in all these frameworks. It will be essential for future European

biotechnology to develop clear and coherent frameworks, and I count on your support to

strengthen this collaboration at EU and national level.

Finally, I would like to draw your attention to the opportunities for support to your national

authorities provided through EU4Health initiatives, in particular the SHARE-SoHO action

which has just started. This action will offer expertise and advice to the national authorities

when preparing for the new SoHO Regulation by summer 2027, including a gap-analyses,

national action plan, training and exchange of know-how.

Do not hesitate to come back to my colleagues in the SoHO team, via SoHO-

[email protected] in case you have further questions or would appreciate a

discussion.

I look forward to continuing the good collaboration.

Yours faithfully,

Sandra GALLINA

cc.: BOIX ALONSO Lorena (SANTE.DDG1), BECKER Rainer (SANTE.D),

MATHIEU-MENDES Agnes (SANTE.D.2), MCGEEHAN Richard (SANTE),

BATTISTINI Luca (SANTE), MOYA DIAZ Marta (SANTE.A.2), VAN DER SPIEGEL

Stefaan (SANTE.D.2), BAERT Katleen (SANTE.D.2), MARCHAND Els (SANTE.D.2),

CICCARELLO Martina (SANTE.A.2)

Electronically signed on 08/12/2025 23:54 (UTC+01) in accordance with Article 11 of Commission Decision (EU) 2021/2121

* * * * * *

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

The Director-General

Brussels SANTE.D.2/KB/eb/(2025)l 1060014

NOTE FOR THE ATTENTION OF Ms KATRIN JUHANDI

DEPUTY PERMANENT REPRESENTATIVE ESTONIA

Your Excellency,

I would very much appreciate if you ensured the delivery of the attached letter to the Director-General (or equivalent) of your Health Ministry.

Commission europécnne/Europesc Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË

Yours faithfully,

Sandra GALLINA

Electronically signed on 08/12/2025 23:54 (UTC+01) in accordance with Article 11 of Commission Decision (EU) 2021/2121

* * * * * *

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

The Director-General

Brussels SANTE.D.2/KB/eb/(2025)l 1060014

NOTE FOR THE ATTENTION OF Ms KATRIN JUHANDI

DEPUTY PERMANENT REPRESENTATIVE ESTONIA

Your Excellency,

I would very much appreciate if you ensured the delivery of the attached letter to the Director-General (or equivalent) of your Health Ministry.

Commission europécnne/Europesc Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË

Yours faithfully,

Sandra GALLINA

Electronically signed on 08/12/2025 23:54 (UTC+01) in accordance with Article 11 of Commission Decision (EU) 2021/2121