13/14 December 2023
The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have updated their questions and answers document on regulatory expectations for medicinal products for human use during the covid-19 pandemic. In the latest revision a new section on "Additional temporary GMP and GDP flexibility" was added.
In this new section, the possibility to "implement temporary changes to certain scheduled quality related tasks" is addressed. These changes in elements of the quality system are possible for the "redirection of resources to focus on supply of crucial medicines". If appropriately justified, these temporary changes "could apply to deferral of certain routine operations such as":
However some pre-requisites need to be considered: