Abstract
Background: Innovative medicines are critical for improving life expectancy and quality of life in patients worldwide. In order to expedite patient access to new medicines, savvy global strategic drug development programs that are well designed to fulfill local regulatory requirements are needed.
Objective: The objective of this paper is to present strategies to enhance globalization and speed to market for innovative medicines.
Results: The following four strategies are highlighted and examined: 1) targeting countries with a demonstrated unmet medical need in the disease area of interest and the infrastructure to support drug registration and launch, 2) harmonizing the regulatory submission dossier, 3) filing simultaneous, harmonized marketing applications in a timely manner and 4) utilizing digital data warehousing technology in combination with drug-development know-how.
Conclusion: Both local and global regulatory intelligence are required to execute forward-thinking strategies for drug development, registration and globalization. By coupling existing know-how with data warehouse technologies, harmonized marketing applications can be simultaneously filed in a systematic manner to countries with specific unmet medical needs. Implementation of these strategies can result in enhanced globalization, speed to market and cost minimization.
Keywords: Globalization, information technology, innovative medicines, new drug application, regulatory procedures, regulatory strategy.
Graphical Abstract
21
4