Regulatory Operations and eCTD Publishing Insights that Accelerate Submission Success
Selecting the right electronic submission services vendor for your organization’s regulatory submissions to health authorities for the approval of new drugs or biologics is a critical decision.
As your company moves towards the regulatory submission of a marketing application to a health authority, there are many things to consider in your project planning.
FDA has more than 300 forms to collect and receive information across a wide range of drug development subjects. In the case of electronic Common Technical Document (eCTD) submissions, there is a specific form (based upon submission type) to be completed and included with every eCTD sequence you submit.
The FDA has released guidance indicating that they will be encouraging the use of new forms FDA 3988 and FDA 3989 to improve the agency’s collection, identification, and use of information regarding PMRs (post marketing requirements) and PMCs (post marketing commitments).
The standard electronic Common Technical Document (eCTD) submission for a New Drug Application (NDA) or Biologics License Application (BLA) includes submission of all five eCTD modules at one time.
We’ve seen recent trends and activity with regards to pharmaceutical regulatory submissions to Health Canada. Several questions and queries have come into our regulatory operations department, and the following information will address a few popular topics.
The U.S. Food and Drug Administration (FDA) has released long-anticipated final guidance with the implementation date for all promotional materials submissions via electronic common technical document (eCTD) format.
Last month, Health Canada announced an update to the mandatory use of the electronic Common Technical Document (eCTD) format. As with other agencies and regions, this helps move Health Canada towards a common submission intake process, as well as standardize and improve its business processes and tools.
The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the structure and implementation rules for the submission of computer readable datasets.
Regulatory submissions must conform to the electronic common technical document (eCTD) format to be successfully received and reviewed by health authorities. And while this might seem simple, this complex technical process is actually rife with risk if you lack expertise in medical writing and regulatory publishing.
In helping clients with their regulatory operations and electronic publishing needs, I’m often asked about preparing regulatory submissions in the electronic common technical document (eCTD) format.
Foreign sponsors of drug applications who want to conduct business in the United States need an authorized U.S. Agent to interact with the FDA on their behalf.