Pharmaceutical Products

White Paper: Global Approval Process for New Pharmaceutical Products and Timelines for Market Applications

Published July 2021


Abstract:

This white paper reviews the global pharmaceutical market share in 2020, world pharmaceutical sales by region forecasted for 2024, as well as the submission process and approval timeline in the U.S., Europe, Canada, Japan, and China.

Keywords: FDA, PDUFA, Priority review, EMA, national procedure, decentralized procedure, mutual recognition procedure, MRA, centralized procedure, API, Health Canada, HPFB, NDA, DIN, Japan, PMDA, MHLW, NMPA

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