That’s what drives a company to hit their submission deadline. The sooner a company gets their submission reviewed, the sooner they’re going to be able to market the product. What happens if a company doesn’t stick to the submission timelines? The decision of the regulatory authorities is a company’s golden ticket The pediatric safety study might be carried out after the drug is approved, but with submission, the company commits to completing this kind of study within a certain time frame. There’s been a lot of changes in the laws over the last few years in the US and Europe, requiring companies to actually look at the performance of their drugs in the pediatric population. For example, nowadays companies actually have to include a pediatric study plan. Īnother part of the dossier submission contains commitments as to what a company will do in phase IV. And the Integrated Summary of Safety (ISS) and the Integrated Summary of Efficacy (ISE) documents hold information about the safety and efficacy of the product. Then it contains data from the clinical side like, how the drug behaves, as well as information about how the drug is produced, which is commonly called the CMC (chemistry, manufacturing, and control) section. So, the dossier submission includes information about the preclinical work, such as the development of the compound and the various animal studies. The CTD is then submitted to the regulatory agencies and they decide whether they will approve it for public marketing or not. Basically, the goal of the CTD is to tell the entire story of a company’s product – of their drug, biologic, or device. Its format is governed by what we refer to as the Common Technical Document (CTD). The dossier submission usually happens after a successful phase III, and the dossier is the vehicle the regulatory agency uses to approve the use of a product. What type of information is included in a dossier submission? The dossier submission is used by the regulatory authorities to decide whether to approve a product for public marketing or not But what goes into such a complex submission? What happens if a submission deadline is missed? How can companies get help? To answer these questions, we have caught up with Mary Mattes, Senior Vice President for Biometrics and Drug Safety at Synteract. Based on the dossier, the product will gain marketing approval – or not. After their early-stage meetings and their initial submissions – the Initial New Drug (IND) application in the US and the Clinical Trial Application (CTA) in Europe – a company’s drug may have reached its pivotal phase III study.Īnd now? The dossier submission – a selection of documents and data that sums up the entire story of how a company’s product developed and evolved. Mary Mattes, Senior Vice President for Biometrics and Drug Safety at Synteractĭuring preclinical research and later on in clinical phases, companies need to be in constant communication with the regulatory authorities, resulting in piles of applications at every step of the way. But a company might have all the money and research it needs, and still fail. It requires highly skilled scientific staff, experienced project managers, and heaps of funding. The process of drug discovery and development is an extremely complex one – we all know that.
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