Now, most of the regulatory bodies around the world are preparing for the transition to version 4.0 of the eCTD Publishing Service. Japan has already started using this eCTD 4.0, while Canada and some other United States will accept this eCTD 4.0 in the next year.
Some other countries are also interested in installing this eCTD 4.0 by 2024. Switzerland & European unions are also in this race; by the end of this decade, new standards will be mandatory for most global regions.
Certain pharmaceutical manufacturers are also trying to transition to eCTD 4.0, and now it’s a good time to review the workflows associated with the eCTD Publishing Service. Now the current requirements for regulatory submissions using the eCTD Publishing Tools are more stringent.
Now, most organizations are focusing on addressing technologies like digital therapeutics and many more. Emerging technologies like wearable medical devices and other digital therapeutics are also promoted.
Data silos also compound the problems. Silos present a great hindrance for the integration of data from disparate sources all across the enterprise and thus meeting the submission deadlines. Most organizations have tried to address this issue by adding some of the staff. And applying automation to the regulatory submission process will bring a twofold benefit of supporting compliance.
Automation technology will benefit the regulation process in 5 major ways, these areas-
• Adopt a new data management framework
• Obtain data directly from its source
• Reuse of the approved data where it is applicable
• Provide notification to the submission request
• Apply changes globally
Amid this transition to eCTD 4.0, it’s very much critical for all those pharmaceutical manufacturers to work with all the experience partners who are ready for this new standard and understand the way to automate and streamline these regulatory publishing workflows at each crucial stage of the process.
Aquila Solutions 