Regulatory Guidelines of the US Food and Drug Administration and the European Medicines Agency for Actively Targeted Nanomedicines
Hacer Coşkun Çetintaş, Hayrettin Tonbul, Adem Şahin, Yılmaz Çapan
Abstract
Guidelines for nanomedicines that are published by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are listed later. This chapter reviews the current FDA and EMA regulatory guidelines for nanomedicines and evaluate their potential for use as reference for actively targeted nanomedicines. The FDA has recommended determining critical quality attributes that have a potential impact on product performance and utilize risk assessments that link structure–function relationships. The FDA recommends considering some points for selecting and using characterization methods. The FDA obligates to manufacture nanomaterials containing drugs in accordance with Good Manufacturing Practices similar to all drug products. The FDA states that all existing International Conference on Harmonization guidelines addressing nonclinical studies be generally applicable for nanomaterials containing drugs. The FDA states that the drug release characteristics of liposomes should be analyzed and release differences between liposomal and nonliposomal formulations should be added to the application.