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eCTD, NeeS and VNeeS

eCTD, NeeS and VNeeS

The challenge

With an increased effort on harmonisation and the inception of ICH in 1990, the process of moving to a more harmonised submission format gained pace. The CTD (Common Technical Document) was agreed in 2000, and shortly after became mandatory in Europe and highly recommended in the US. Companies were able to exchange a common dossier format with agencies, although at present still in paper and only one way.

With electronic aids becoming available, work in the ICH started to implement an electronic format, later to be known as eCTD, the electronic Common Technical Document. The eCTD became a standard first of all in the ICH regions, but was later adapted by Canada and Switzerland with others to follow.

Wherever and whenever the full adaptation of the eCTD was not yet possible or seen as not practical, a simpler format and process established itself later to be known as NeeS, the Non-eCTD electronic Submission format.

In the veterinary field, the NeeS equivalent, VNeeS, was introduced in the EU in October 2015, bringing the requirement for electronic submissions into the veterinary world too.

The solution

With Samarind RMS, moving from paper via NeeS to eCTD is simple and cost effective and can, should this be required, be done step by step. Supporting the Emerging Dossier Concept with its Single Place of Truth, Samarind RMS guides the user through the dossier creation process from the medicinal product via documents to final submission. The reuse of pre-entered information such as manufacturer for Module 3, submission type for the envelope or region to determine submission procedure, business rules ensure correct data allocation and thereby minimising date entry mistakes, misspelling or worse, wrong data allocation.

For veterinary submissions, Samarind RMS supports the pharmaceutical, immunological and MRL application types too.

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