the european medicines agency (ema)

What are the Key Guidelines for Nanomedicines?

The EMA has published several guidelines to aid in the development and evaluation of nanomedicines. These include the Reflection Paper on Nanotechnology-Based Medicinal Products for Human Use, which outlines considerations for quality, non-clinical, and clinical aspects. Additionally, the Guideline on the Quality, Non-Clinical and Clinical Aspects of Medicinal Products Containing Nanomaterials provides detailed requirements for the characterization and testing of nanomaterials.

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