Current Regulatory Status and Challenges of Pharmaceutical Excipients

Abstract

 Pharmaceutical excipients are essential components of drug formulations, playing crucial roles in improving their stability, solubility, manufacturability, and ease of administration. However, the globalization of pharmaceutical supply chains has introduced new challenges in quality control. In particular, recent cases of diethylene glycol (DEG) and ethylene glycol (EG) adulteration in pharmaceutical excipients have emerged as significant public health threats worldwide. Various regulatory measures have been implemented to address these issues, including specific purity tests in individual pharmacopoeias and the World Health Organization’s proposed two-level approach for DEG/EG testing. To ensure both quality assurance and a stable supply of pharmaceutical excipients, strengthening international cooperation among regulatory authorities, pharmaceutical companies, and excipient manufacturers is critical. In this review, we discuss the regulatory framework for pharmaceutical excipients, with a focus on the Japanese Pharmacopoeia, and efforts toward international harmonization through the Pharmacopoeial Discussion Group.