Pharmaceutical regulators are becoming more cautious about approving innovative medicines for consumers’ safety. The US Food and Drug Administration (FDA) has established many regulations that govern the development, testing and production processes of drugs. As part of streamlining these processes and addressing the cost trends, FDASIA (FDA Safety and Innovation Act) has redirected generics and biosimilars companies to file submissions electronically from May 5, 2017 and pay user fees to the FDA.
In the absence of electronic document management, quality management and submission management systems, pharmaceutical companies will find it tough to do business with FDA and also with their own governments as it was done earlier. Electronic Common Technical Document (eCTD) is an interface through which pharma companies can transfer regulatory information to agencies like the FDA. This interface is supported and enabled by enterprise Document Management Systems (eDMS).
Section 745A(a) of the Federal Food, Drug, and Cosmetic (FD&C) Act states content should be submitted in electronic format in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and investigational new drug applications (INDs) to the Center for Drug Evaluation
and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). Submissions in other formats, barring the ones under section 561, will not be considered for filing.
These mandates will have considerable impact on pharmaceutical companies that are still using paper-based documentation and allows the transition to an industry standard eDMS and eCTD. Also impacted by this would be generic drug and biosimilar manufacturers currently not meeting the industry standards giving them an opportunity
to improve their businesses by being a part of more unified global industry. With benefits like reducing automation and storage costs by having all data in a centralized electronic environment, regulators and pharma companies will enjoy streamlined workflows in development, regulatory and marketing departments with increased collaboration between teams.
Now is the time for management of pharmaceutical companies to come forward and comply with stringent FDA mandates.
In this issue, the article ‘The Electronic FDA Submissions - Is APAC Prepared for the 2017 Mandate?’ by Warren Perry, of Dassault Systèmes BIOVIA, USA, explains how generic drug companies have to align their businesses with policies and how FDA is directing companies towards making electronic submissions.