Outside Support — Supporting Marketing Authorization Applications with Non-Clinical Overviews

EPM
August, 2017
Author: Dr. Rajendra Wable, Sciformix Corporation

The origin of the non-clinical overview (NCO) is from the twin directives 75/318/EEC and 75/319/EEC issued on 20 May 1975. Directive 75/319 article 2 indicates that the marketing authorization application should provide an assessment of the pharmacotoxicological data and annex 1 of directive 75/318 refers to such assessment as an ‘expert report’.

Today, much care and many resources must be applied to non-clinical data to ensure that the three elements of overview, written summary and tabular summary tell the same story and give the same interpretation, especially if the authors of each part are not the same.1 As such, the complexity of regulatory writing is at an all time high, and the intensity and skill level required is constantly expanding.

Furthermore, over the past decade regulatory submission requirements have grown substantially, in part due to the increased product registrations in the EU, Australia and other countries. Many organizations from small to the top pharmaceutical companies struggle to fulfill their non-clinical regulatory writing and submissions in a timely manner and therefore require assistance from external sources.

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