This four-part story explores the significant impact of the pandemic during 2020-2021 on the CMC review processes for vaccines and biotherapeutics at FDA, EMA and Japan’s PMDA in their efforts to support accelerated product development and review, while assuring that quality standards are met and the ongoing non-COVID-related workload addressed.
Part I: EMA Perspective
Part II: FDA CBER Perspective
Part III: FDA CDER Perspective
Part IV: Panel Discussion Among US, Europe, and Japan Regulators