A few months ago, GxP Perspectives discussed eCTD as a Required Format
for FDA Submissions. To summarize, in PDUFA V Commitment Letter
8-31-2011, the agency announced their intention of issuing draft
guidance for required electronic submissions in eCTD format by December
31, 2012, with final guidance no more than 12 months after the close of
the public comment period. Twenty-four months after publication of the
final guidance, electronic submissions will be required for all new NDA
and BLA submissions (originals, supplements and amendments) with a few
specified exceptions. In this update, Kathie Clark discusses upcoming
requirements, developments, and incentives for sponsors of clinical
research.
Recent eSubmission-Related Regulatory Developments and the Impact on Sponsors - by Kathleen Clark
The regulatory authorities have been busy announcing plans and
issuing new guidance related to eSubmissions in recent months.
Legislation has been proposed to expedite review of generic drug
applications and improve communication between FDA and industry –
Generic Drug User Fee Act Program (GDUFA). GDUFA includes goals for FDA
such as reviewing and acting on 90% of complete ANDAs within 10 months
after the date of submission – but these goals only apply to submissions
made electronically, following the eCTD format.
New Initiatives in Europe
New Developments in Europe
In
Europe, the big news has been the eXtended EudraVigilance Medicinal
Product Report Message (XEVPRM). XEVPRM is an XML-based message format
that defines the structure and data elements required to unambiguously
identify a medicinal product. European Medicines Agency requires that by
July 2, 2012, information on medicinal products for human use
authorized or registered in the Union is submitted electronically in
this format. Sponsors are scrambling to meet this mandate as guidance
has been finalized only recently.
Sponsors are often challenged to locate the data
needed for submission, and ensure that it is complete and accurate.
Vendors have been following the initiative closely, but even so,
deploying and validating systems to publish the new message and putting
in place the business processes around their use is a significant
effort. Some aspects of the mandate remain unclear.
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