Comparative Regulatory Testing Requirements Publisher



Mousavi T^{1, 2} ; Abdollahi M^{1, 2}
Source: Encyclopedia of Toxicology# Fourth Edition: Volume 1-9 Published:2023

Abstract

Since the first cases of thalidomide-induced birth defects and chloramphenicol-induced aplastic anemia, there have been significant improvements in the overall toxicity assessment of products. However, adverse drug events (ADEs) still contribute to many hospitalizations and deaths worldwide, which might be due to administration, formulation or safety issues in different development steps from the preclinical stage to post-marketing surveillance. This is where the role of regulators becomes prominent, and imposing necessary legislation seems vital. Through reviewing global and national guidelines, you will get acquainted with the toxicity requirements in preclinical and clinical settings in this chapter. Besides, you will understand how essential international regulators differ in legislating medications, biologics, foods, cosmetics, medical devices, animal and veterinary products, considering the safety aspect. © 2024 Elsevier Inc. All rights reserved.