New criteria for ATMPs which must follow quality rules defined by the G-BA in Germany.
Since February 4th 2023 the Federal Joint Committee (G-BA) has brought a rule into force for when it may require additional assurances of the quality of an Advanced Therapy Medicinal Products (ATMP). An ATMP can be considered a candidate for the quality rule if any of the following apply (though other medicinal products may also be considered):
- They have an increased risk potential or one that cannot yet be adequately assessed compared to current therapy standards in the same field of application
- Their application (indication, preparation, implementation or aftercare) is particularly complex and cross-sectoral and interdisciplinary
- There are indications of existing or expected quality deficits in the use of the ATMP, for example in infrastructure at centres that will deliver the ATMPs
- They are suitable for a relevant number of patients
To assess the criteria above, the G-BA will consult other studies and registry data as well as approval documents, interviews with manufacturers and expert hearings. The G-BA intend to decide on the quality assurance requirements within 9-months and this will happen shortly before a decision is made. However, the G-BA can begin to advise on likely quality assurances once marketing authorisation has been applied for.
- ATMP: G-BA legt Aufgreifkriterien für Qualitätsregeln in seiner Verfahrensordnung fest. G-BA. https://www.g-ba.de/service/fachnews/56/. Accessed 8th February 2023