How Does the EMA Ensure the Safety of Nanomedicines?
The EMA employs a rigorous evaluation process to ensure the safety of nanomedicines. This process includes:
Preclinical Studies: Comprehensive studies to assess the pharmacokinetics, pharmacodynamics, and toxicology of nanomedicines. Clinical Trials: Well-designed clinical trials to evaluate the safety and efficacy of nanomedicines in human subjects. Post-Market Surveillance: Continuous monitoring of nanomedicines after they are approved to identify any long-term safety concerns.
