In a recent conference held by the USFDA, Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions - the FDA discussed two (02) topics, namely -

  • Drug Master File (DMF) enhancements specified under the Generic Drug User Fee Amendments (GDUFA) III Commitment Letter
  • An update on the future state of DMF submissions and assessments

At the conference, the benefits of cloud-based Regulatory submissions were lauded as they ensure consistent product reviews. Also, the delegates described how the Agency is driving towards this platform through various initiatives to modernize the Regulatory submission process.

Much progress has been made in modernizing Regulatory submissions - from truckloads of paper documents to CTD and then electronic CTD (eCTD). But in today’s digital world, these Regulatory submissions are outdated as they are static snapshots in time versus individual documents that are prone to errors, and it is cumbersome to access PDF content.

Also, the industry complains that reviews are inconsistent as one assessor would not know what other assessors have concluded for the same/similar products. A cloud-based system allows data to be readily exchanged between regulators and companies. The companies will inform the USFDA when a product dossier is ready for assessment, and then the USFDA can access and analyze the data from the cloud environments. The use of a cloud-based system for Regulatory assessment enables a dynamic exchange of information between the regulators and the industry.

In a nutshell, the USFDA is finding ways to speed up and simplify the Regulatory submission process by adopting cloud-based technology. These, for sure, will enhance how regulators and companies communicate and harmonize the process. But what will be the reality? Let us wait for the next FDA update. Until then, decode more on other formats of submissions, either Paper-based or electronic. Consult Freyr today!


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