Worldwide Drug Planning System: An Automated System of Registration Requirements and its Application for Regulatory Planning and Strategies

Abstract

The Worldwide Drug Planning System was developed as part of an integrated network of regulatory information which exists in Regulatory Affairs-International (RA-I). The primary objective of this Worldwide Drug Planning System is to provide RA-I personnel with a mechanism to assist in the planning for the worldwide registration of product candidates. The system consists of four basic parts. The first is a database of country requirements to obtain clinical study authorizations and marketing authorizations. The second is a database of project status information specific to each product under development. The third and fourth pieces are simulation programs which help determine scenarios and strategies for clinical study authorizations and marketing authorizations.