Statement on European Commission's Proposed 'Substance of Human Origin' Regulation

Washington, DC – July 14, 2022

Stephen Majors, Senior Director for Public Affairs

The European Commission’s proposed ‘Substances of Human Origin’ (SoHO) Regulation holds the promise of improving patient safety while establishing greater legal and regulatory certainty across the EU.

The proposal is of great relevance to Advanced Therapy Medicinal Product (ATMP) developers because SoHOs are most often used as starting materials for the development and manufacture of ATMPs. Clear regulatory distinctions between starting materials and ATMPs are needed to enable a predictable regulatory framework across the EU for both patients and developers.

The EU’s ATMP classification has established the region as a global leader in the regulation of cell and gene therapies, which can provide durable treatments and possibly cures for serious diseases.

The process to determine the classification of ‘borderline’ cases – especially those that fall in between SoHOs and ATMPs – must reflect that the European Medicines Agency holds the highest scientific and patient safety standards on which product classification decisions should be based. The EMA’s authority would facilitate harmonization and regulatory predictability across the EU.

ARM looks forward to working with European decision-makers on legislation that prioritizes the safety of EU patients, provides legal and regulatory certainty, and maintains the highest global regulatory standards around the development of transformative cell and gene therapies.