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New EU Regulation 2024/1938 on Substances of Human Origin

Date
July 25, 2024
Category

EU Regulations

Description

A new Regulation on standards of quality and safety for substances of human origin (SoHO) intended for human application was signed by the EP and the Council of the EU on 13 June 2024 and published in the Official Journal on 17 July 2024 as Regulation 2024/1938. This new Regulation repeals the current Blood Directive 2002/98/EC and the Tissues and Cells Directive 2004/23/EC. The majority of the provisions in the new Regulation will be implemented from 7 August 2027. Other provisions in the new Regulation will be implemented as follows:

  • the Commission may adopt the delegated and implementing acts required from 6 August 2024,
  • the provisions regarding the setting up of the SoHO Coordination Board apply from 7 August 2024,
  • the requirement for Member States to set out rules on penalties applicable to infringements and the provisions for transitioning from the current Blood Directive 2002/98/EC and the Tissues and Cells Directive 2004/23/EC, apply from 7 August 2028

The regulation defines SoHOs as “any substance collected from the human body, whether it contains cells or not and whether those cells are living or not, including SoHO preparations resulting from the processing of such substance”. The regulation covers the use of SoHOs in medicines, advanced therapies, starting materials for producing investigational medicinal products, and stem cell transplants for blood cancers and other conditions.

The new regulation requires EU Member States to designate a SoHO national authority and other competent authorities to authorise SoHO preparations and ensure independent and transparent oversight of SoHO related activities.

The regulation also sets out further requirements for authorisation and inspection of establishments that process and store, release, import and export such substances.

A rapid alert system is to be set up to deal with serious reactions and incidents affecting recipients or donors. Member States are also encouraged to create national emergency plans to include measures to respond to critical shortages.