EMA warns against unapproved cell therapies

Regulatory NewsRegulatory News | 28 April 2020 |  By 

Following the recommendation of its Committee for Advanced Therapies (CAT), the European Medicines Agency (EMA) on Tuesday warned patients against using unapproved and unregulated cell therapies, citing serious and potentially fatal side effects.
Across the Atlantic, the US Food and Drug Administration (FDA) has repeated similar warnings for years and has sent numerous warning and untitled letters to manufacturers, distributors and clinics for marketing unapproved stem cell therapies. (RELATED: FDA to Step Up Stem Cell Enforcement, Look Into Pathway for Low-Risk Treatments, Regulatory Focus 3 April 2019; Stem Cells: FDA Continues Enforcement Effort With Letter to Florida Supplier, Regulatory Focus 22 November 2019).
EMA says the warning was prompted by “the appearance of advertisements for cell therapies as cures for serious conditions across the European Union in early 2020,” and serves to replace a decade-old warning against unregulated stem-cell products.
“Patients using unproven or unregulated cell-based therapies have reportedly suffered serious, sometimes fatal, side effects including infections, unwanted immune reactions, tumor formation, loss of vision and bleeding in the brain,” EMA says, explaining that when cells are used for different functions in a recipient or are substantially manipulated, such products are regulated as medicines.
EMA notes that cell-based therapies hold promise for treating patients with serious diseases but says that well-designed clinical trials and regulatory oversight are necessary to ensure the safety, efficacy and quality of the therapies.


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Tags: EU

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