In order to better explain the flexibilities introduced to manage the coronavirus pandemic, the European Commission (EC), European Medicines Agency (EMA) and the European Medicines Regulatory Network have published a Q&A.
According to the authors:
“The Q&A document outlines areas where regulatory flexibility is possible to address some of the constraints marketing authorisation holders may be faced with in the context of COVID-19. The measures introduced cover different areas of the regulation of medicines such as marketing authorisations and regulatory procedures, manufacturing and importation of active pharmaceutical ingredients (APIs) and finished products, quality variations, and labelling and packaging requirements with flexibility to facilitate the movement of medicinal products within the EU. Some of the measures described are reserved for crucial medicines for use in COVID-19 patients.”
Featured questions include:
- Can medicinal products intended for use in COVID-19 patients be marketed in the absence of a marketing authorisation?
- Can I postpone my renewal application?
- Does the ‘sunset clause’ apply during a pandemic?
All manufacturers, especially those producing potential treatments for COVID-19, should review the Q&A for more detail on how to work with EMA during the pandemic.