Experimental. Legal. Transparent.

What ANOVA IRM's regulatory status means for patients

International medicines authorities rightly warn against unregulated and insufficiently tested cell therapies. ANOVA IRM has therefore summarised its regulatory status openly and in a publicly verifiable way. Our treatments are experimental, but they take place within a legally regulated framework that is supervised by the authorities.

Read ANOVA IRM's full regulatory status

The topics at a glance

Part 1: Experimental is not the same as illegal

“Experimental” describes the state of the clinical efficacy data. “Legal” describes whether the legally required authorisations and official oversight are in place. The two must be considered separately.

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At a glance: the official authorisations

For BMC, ANOVA IRM holds a manufacturing authorisation under Section 13 AMG and an EU GMP certificate; for the MSC process, authorisations under Sections 20b and 20c AMG are in place. The evidence is publicly verifiable.

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Who oversees ANOVA IRM? The medicines authorities in Germany

The competent state authority, HLfGP, supervises and inspects manufacturing; the Paul-Ehrlich-Institut is the competent federal higher authority for biomedical medicines and ATMPs.

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Publicly verifiable evidence

The manufacturing authorisation and GMP certificate can be traced via EudraGMDP; the registration as a tissue establishment can be viewed in the EU Tissue Establishment Compendium.

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BMC: officially authorised manufacturing under GMP

BMC is manufactured and tested individually for each patient from autologous bone marrow, within the authorised manufacturing scope and under European GMP requirements.

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MSC secretome: officially authorised tissue preparation — voluntarily at ATMP level

The procurement and processing of the patient's own tissues and cells take place under the authorisations pursuant to Sections 20b and 20c AMG. For this process, ANOVA IRM additionally applies a quality level based on ATMP structures.

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Important clarification: legal and controlled ≠ approved

Official manufacturing and processing authorisations are not the same as an indication-specific marketing authorisation. The treatments remain experimental and are carried out following an individual medical benefit-risk assessment and informed consent.

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Regenerative medicine is complex. Transparency about manufacturing, quality and regulatory status should not be.

Our commitment: to state clearly what is documented – and equally clearly what remains experimental.

View all authorisations, registers and explanations

Note: This newsletter provides information about the regulatory framework. It does not replace individual medical advice.