The NeeS submission format, i.e. Non-eCTD electronic submissions, will come to an end for EU Marketing Authorization applicants and holders (MAH) from January 1st, 2018. This marks the start of a range of major developments between now and 2020 around CP, DCP, MRP and NP submissions.
What is an eCTD?
A CTD describes the organization of modules, sections & documents used by an applicant for MAH for a medicinal project.
The eCTD (electronic common technical document) format was first introduced in 2002 with the option to send an eCTD in a parallel with paper submission CTD from June 2003. By June 2010, it became mandatory for all CP procedures to be in eCTD format. The 5 modules within the eCTD format cover all necessary regulatory information for submitting applications, amendments and the agency transfer of regulatory information.
NeeS vs eCTD
The NeeS format lacks the electronic metadata and XML table of contents of the eCTD format; the “backbone” that allows easy navigation throughout an eCTD document.
Data protection is another concern with the NeeS format as it does not possess the MD5 security system within eCTDs.
The timetable for change
Of course, there will be some difficulties, for example not all NCAs (National Competent Authorities) are the same, each to their own and as a result whilst some countries may have everything set in stone to meet deadlines, others may need more time to update their processes to comply with the new changes.
How Arriello can make the transition easy
Unsure of the next steps? See how we can make the transition faster, better and smarter by contacting email@example.com