Considerations for the chemistry, manufacturing and Controls (CMC) - quality package for COVID-19 vaccines- interim lessons learnt by the European medicines Agency (EMA)

Abstract

The European Medicines Agency (EMA) has approved five pandemic COVID-19 vaccines (prior to April 2022) and many others are in the pipeline. The commentary describes how timely approval and rapid manufacturing capacity scale up could be achieved from our perspective.The commentary considers the need for: early, continuous engagement with the regulator for COVID-19 vaccines; understanding key Chemistry, Manufacturing and Controls (CMC) challenges in order to build a successful COVID-19 vaccine CMC dossier; investing in production and testing site readiness for COVID-19 vaccines; CMC Lifecycle and post-approval planning for COVID-19 vaccines as well as future directions including international regulatory cooperation.EMA’s experience of the CMC scientific considerations, which facilitated both timely approvals (as Conditional Marketing Authorisations) and rapid increase in production capacity and supply, is of interest to healthcare professionals, academia, pharmaceutical industry and global regulators to communicate the flexibility and agility applied to COVID-19 vaccines by the EU regulatory system and how these activities can be optimised while complying with the strict quality standards in the EU.