MEDICINE RECALL SYSTEMS IN THE USA AND EU: A REGULATORY COMPARISON

HAXHIU ZAJMI, Arlinda and YZEIRI HAVZIU, Drita and ALIJA, Gjylaj and SHABANI, Arijeta and DAUTI, Merita and RUSTEMI AHMETI, Hanife and CILKU, Elona and MUSTAFA, Zana (2026) MEDICINE RECALL SYSTEMS IN THE USA AND EU: A REGULATORY COMPARISON. In: INTERNATIONAL CONFERENCE “FROM RESEARCH TO APPLICATION”, 20 May, 2026.

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Abstract

Medicine recall was an essential regulatory mechanism designed to protect patients from medicines that were unsafe, ineffective, or of poor quality. It involved the removal of specific batches or lots of medicinal products due to issues such as manufacturing defects, contamination, or labeling errors, whereas withdrawals referred to the permanent removal of an entire drug product from the market. The reasons for medicine recalls varied and, depending on the level of risk to patients, recalls were carried out at different levels of the supply chain, ranging from distributors and pharmacies to patients themselves. The aim of this study was to analyze and compare how this system was organized in the United States and the European Union. The methodology was based on the analysis of scientific literature and statistical data obtained from official reports of the U.S. Food and Drug Administration and the European Medicines Agency. The findings indicated that, despite differences in structural organization, implementation, and levels of transparency, both regulatory systems aimed to protect patients and ensure the quality and safety of medicines. The study highlighted that effective recall procedures and regulatory coordination played a crucial role in minimizing risks associated with defective medicinal products. Overall, continuous improvement in recall mechanisms, strengthened regulatory cooperation, and compliance with relevant standards and regulations by pharmaceutical companies were essential for enhancing pharmaceutical safety at both national and international levels.

Item Type: Conference or Workshop Item (Paper)
Subjects: Q Science > Q Science (General)
Divisions: Faculty of Law, Arts and Social Sciences > School of Social Sciences
Depositing User: Unnamed user with email zshi@unite.edu.mk
Date Deposited: 10 Sep 2026 13:35
Last Modified: 10 Sep 2026 13:35
URI: http://eprints.unite.edu.mk/id/eprint/2402

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