On 8 May 2025, the European Medicines Agency (EMA) opened a consultation on revising the GMP guidelines for Advanced Therapy Medicinal Products (ATMPs), with implications for products involving nanomaterials. The revision aims to align ATMP manufacturing with updated Annex 1 provisions on sterile production and to integrate quality principles from ICH Q9 (risk management) and ICH Q10 (quality systems). This is particularly relevant for ATMPs that incorporate nanomaterials (e.g., lipid nanoparticles used in gene therapies or nano-engineered scaffolds in tissue-engineered products).
The draft concept paper explicitly encourages the qualification of closed systems, isolators, and novel technologies—all essential for safely handling nanoscale materials that pose unique contamination and exposure risks. The document also incorporates recent EU legislation on substances of human origin and calls for updated standards for starting materials, which could impact nanoform inputs. Stakeholders developing or regulating nano-enabled ATMPs are encouraged to participate in the consultation, open until 8 July 2025, to ensure the framework supports the safe and effective integration of nanotechnology in advanced therapies.
Learn more and participate here.
