Abstract
The quality of biopharmaceuticals is carefully monitored by manufacturers and regulators to ensure safety and efficacy throughout the entire product life cycle. Quality defects can lead to post-approval regulatory actions (RAs) to inform healthcare professionals (HCPs). The present study identified quality-related RAs for biopharmaceuticals approved in the European Union and United States between 1995 and 2019. Quality-related RAs were issued due to various quality defects and required different actions by HCPs. The quality defects were not identified due to a negative impact on efficacy and/or safety, which is reassuring. The findings reflect the capability of the stringent regulatory system and quality control to capture and counter various quality defects before the affected product and batches can harm patients.
Original language | English |
---|---|
Article number | 103725 |
Number of pages | 7 |
Journal | Drug Discovery Today |
Volume | 28 |
Issue number | 10 |
Early online date | 23 Jul 2023 |
DOIs | |
Publication status | Published - Oct 2023 |
Bibliographical note
Funding Information:This study was funded by the Saudi Food and Drug Authority (SFDA) as part of a PhD project for A.M.A. The SFDA has no role in any aspect of the study, including the preparation, review, the approval of the manuscript, nor the decision to publish the manuscript.
Publisher Copyright:
© 2023 The Author(s)
Keywords
- biopharmaceuticals
- biotechnology
- critical quality attributes
- post-approval quality surveillance
- regulatory actions
- regulatory science