Amidst the COVID-19 pandemic, extraordinary regulatory flexibilities were introduced for medicines, effectively tackling regulatory and supply challenges. These flexibilities ensured a continuous supply of safe and effective medicines while maintaining strict adherence to good manufacturing (GMP) and distribution practice (GDP) standards.
The following are some of the flexibilities that were implemented:
The flexibilities were carefully monitored by the EMA, and there is no evidence that they had any negative impact on the safety or quality of medicines.
Now that the pandemic is coming to its end, the EMA, the European Commission (EC), and the Heads of Medicines Agencies (HMA) are phasing out these flexibilities. This is an important step in ensuring the continued safety and quality of medicines. Some examples of this phased out approach are:
The EMA, EC, and HMA will continue to monitor the situation and may introduce new flexibilities if necessary to protect patients. However, for now, the focus is on phasing out the existing flexibilities in a smooth and orderly manner.
The EMA is also collecting data on the experiences of companies and regulators with the COVID-19 regulatory flexibilities. This data will serve as a crucial foundation for developing effective strategies to tackle medicine shortages in response to any potential new and emerging health challenges in the future.
For more information on the regulatory expectations for medical products for humans used during the COVID-19 pandemic, read:
For more information on the phase out process, read: