A review of documentation requirements for preclinical sections, for marketing submissions in the European Community, Japan and the USA.
Standardization of the documentation requirements for preclinical sections, for marketing submissions in the European Community (EC), Japan and the USA is proposed. It is unnecessary to standardize the leading summaries of submissions as their format is predicated by the way in which the regulatory authorities review applications. Harmonization of the technical sections will reduce the duplication of effort expended by pharmaceutical companies to produce documentation specific for each regulatory authority. Elimination of requirements specific to individual authorities will further reduce the resource requirements. The proposals made in this paper are aimed to increase the 'user-friendliness' of the preclinical documentation and therefore expedite the review process.
Marr
A P
AP
Glaxo Group Research Ltd., Ware, Hertfordshire, UK.
Scales
M D
MD
D000818:Animals; D004353:Drug Evaluation, Preclinical / Q000379:methods / Q000592:standards*; D005060:Europe; D007564:Japan; D014481:United States