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PharmTech.com Quality and Regulatory Sourcebook eBook March 2024 Pharmaceutical Technology ® 35 leowolfert - Stock.adobe.com R egulatory submissions are a critical step in bringing new drugs and medical interven- tions to market, and the success of these submissions heavily relies on the quality and fitness of the data presented within the submis- sion package to regulatory bodies. Recent FDA anal- ysis shows that 32% of study data in submissions had significant issues with data conformity. If a submis- sion is rejected due to non-conformance with study data requirements, it does not progress to the FDA Electronic Submissions Gateway, nor does it enter FDA electronic document rooms, which is where the official FDA review process begins. Out of the new new molecular entity (NME)/investigational new drug (IND) applications that successfully pass the study data conformance screening, only 50% are approved by FDA on their first submission. There is then a median delay of 435 days to approval follow- ing the first unsuccessful submission, which in turn postpones the availability of crucial new medications to patients. The stringent requirements set forth by regulatory bodies such as FDA and the European Medicines Agency (EMA) are not just procedural hurdles, they are essential safeguards to ensure the integrity of the clinical trial process, patient safety, and drug efficacy. The rapid advancements in medical science and data technolog y result in both oppor tunities and challenges in maintaining the highest standards of data quality. As the industry navigates through the complexities of clinical trials, the importance of accurate, reliable, and robust data cannot be un- derstated. Data must accurately ref lect the clinical trial's findings, as inaccuracies can lead to incorrect conclusions about a dr ug's safet y and ef ficacy, ul- timately affecting patient health and public safety. This is why adherence to standards such as those provided by the Clinical Data Interchange Standards The Importance of Quality Data for Regulatory Submissions Claude Price is the head of Clinical Data Management at Quanticate. Regulatory submissions are a critical step in bringing new drugs and medical interventions to market, the success of which heavily relies on the quality and fitness of the data presented to the regulatory bodies.