Background

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.

Regulator Flexibilities

The following are some of the flexibilities that were implemented:

• Marketing authorization: The European Medicines Agency (EMA) was able to accelerate the marketing authorization process for COVID-19 vaccines and treatments. This was done by streamlining the review process and allowing companies to submit certain data later.

• Manufacturing: Companies were granted flexibility to use alternative manufacturing sites and processes, ensuring a continuous supply of medicines. The EMA had already approved these alternatives while maintaining strict quality control standards.

• Importation: Companies were permitted to import medicines from countries not normally approved for export, providing patients access to unavailable medicines.

• Quality variations: Companies were allowed to make changes to medicine composition and manufacturing without full regulatory approval, enabling swift responses to pandemic changes.

• Labelling: The EMA allowed companies to use simplified labelling for COVID-19 vaccines and treatments, such as English-only labelling for COVID-19 vaccines, to enhance understanding and patient access.

• GMP and GDP inspections: The EMA allowed companies to postpone or conduct remote GMP and GDP inspections during the pandemic.

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.

Future Measures

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:

• Labelling flexibilities: The application of labelling flexibilities, such as English-only labelling for COVID-19 vaccines, will be extended until the end of 2023. After that, companies will need to follow the regular mechanisms for obtaining labelling exemptions.

• GMP and GDP inspections: On-site GMP and GDP inspections have been restarted after being postponed or carried out remotely during the pandemic. However, a considerable number of postponed inspections still need to be carried out. The validity of GMP and GDP certificates has been extended until the end of 2023. The GMDP Inspectors Working Group will issue an update on the approach for 2024 in the coming months.

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.

List of References

For more information on the regulatory expectations for medical products for humans used during the COVID-19 pandemic, read:

https://health.ec.europa.eu/system/files/2023-07/guidance_regulatory_covid19_en_0.pdf

For more information on the phase out process, read:

Phasing out of extraordinary COVID-19 regulatory flexibilities | European Medicines Agency (europa.eu)