Dr Rajendra Wable, subject matter expert-medical writing and regulatory affairs at Sciformix Corporation, discusses how marketing authorisation applications across Europe, Australia and other countries can be supported with non-clinical overviews.
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’.