The backlog of inspections caused by the COVID-19 pandemic is expected to have long-lasting effects on the pharmaceutical industry, causing delays in the approval of new drug applications and product launches. Regulatory agencies have implemented measures to address this backlog, including prioritizing inspections of higher-risk facilities and utilizing remote inspection capabilities. Despite the tragic nature of the pandemic, it is undeniable that several lessons have been learned from this ordeal. As a result, we have gained insights into the effectiveness of remote inspections, the importance of mutual recognition agreements, the necessity for adaptability and clear communication, as well as the value of virtual audits and remote document review.
The consulting firms in the pharmaceutical industry have also encountered their own set of challenges due to the pandemic, resulting in increased competition and heightened client expectations. This article aims to explore the difficulties faced by the pharmaceutical industry during the COVID-19 pandemic, specifically regarding regulatory inspections conducted by the FDA and EMA.