Phasing out of extraordinary COVID-19 regulatory flexibilities

July 6, 2023

The European Medicines Agency (EMA) has officially declared the gradual discontinuation of exceptional regulatory flexibilities that were put in place during the COVID-19 pandemic.

These flexibilities have been implemented to streamline the process of developing, authorizing, and making medicines and vaccines available for combating the virus. As the ongoing pandemic continues to develop and vaccination campaigns make progress, the European Medicines Agency (EMA) is focused on resuming regular regulatory procedures while also ensuring the essential flexibility to effectively address any potential future challenges. The agency emphasizes the significance of maintaining the ongoing safety, quality, and effectiveness of medicinal products, while also recognizing the persistent requirement for attentiveness in monitoring and addressing emerging COVID-19 variants. The European Medicines Agency (EMA) would like to assure the public that their dedication to safeguarding public health remains unwavering. They are committed to continuously adjusting their regulatory approach, as needed, to ensure the protection and well-being of individuals throughout the European Union.


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