Enabling Multi-region submissions, effortlessly
While concluding our recent blog post on the Health Canada and the FDA’s DMF Submission mandates, we’ve realized how difficult and time-consuming was it for pharmaceutical companies to go for multi-region drug approvals especially when there was no scope of electronic information processing.
To start with the advent of Common Technical Document (CTD), pharma companies had the option to create submissions around the world with a common organizational structure. They had the facility to reuse maximum parts of submissions of one region for the other region, conditionally. Back then, the companies would go for drug approvals through complex paper submissions. They would seek approvals in one region first and then they would go for other regions with high possibility of effort-overlapping and submission format variation.
The commencement of electronic submissions (with eCTD) streamlined the processes further. All thanks to the new process, companies are now capable of reusing and managing the submission format of one region to multiple regions without any need to overlook the submission process all again. That reduced the maintenance complexities and they are now easily focusing on drug approvals for various markets, at the same time. Though the new submission process reduces the need for meticulous documentation, compilation and rigorous validation, the amount of hard work required in terms of managing the resources for simultaneous submissions poses a great challenge.
Every new filing for every new region has its own challenges; the number of follow-ups and the responses following initial submissions, etc. In addition, resources, having been working for multiple submissions simultaneously, may exhaust and fall short at critical times. As a result, companies may be vulnerable to balance too much of work with very few resources. So the question arises, are electronic submissions: a boon or bane?
To make the situation any better, the best is to implement a proper plan and communication for streamlined electronic submissions. A clear-cut analysis on a number of submissions to be handled, available resources, and post-filing requirements/commitments, ensures better quality in the submission processes. It will help companies not only to fall in line with multi-region mandate requirements within timelines, but also to manage the high quality submissions lifecycle, thoroughly.
To conclude, electronic submissions, with proper plan and execution, are definitely a boon to Pharma and Lifesciences industries in order to get multi-region drug approvals simultaneously. With the reduced rework on documents, it saves considerable time and proven to be cost-effective, too.
To chalk out your region-wise dossier development and submissions plan for faster drug approvals, it is recommended to consult an exclusive Regulatory Submission & Publishing partner. Read how Freyr helped one of its clients to fast-track ANDA submissions within just 3 weeks.