EMA: Expiration of Extraordinary COVID-19 Regulatory Flexibility

On 6 July 2023, the European Medicines Agency (EMA), the European Commission (EC) and the Heads of Medicines Agencies (HMA) announced that they were phasing out the extraordinary regulatory flexibilities for medicines that were effective during the COVID-19 pandemic.

This follows the end of the COVID-19 public health emergency declared by WHO in May 2023.

During the global pandemic, steps were taken to ensure the continuous availability of medicines that meet the applicable GMP and GDP standards.

The different areas that were given special regulatory flexibility as a result of the declared state of emergency are

• the marketing authorisation and related regulatory procedures,
• the manufacture and import of active pharmaceutical ingredients and finished products,
• the labelling and packaging requirements,
• quality variations and
• regulatory compliance.

The flexibilities that the three authorities declared during the pandemic will no longer be granted. Already approved operations that fall under the special regulatory flexibilities are scheduled to expire at the end of 2023. These include e.g.:

• English-only labelling for COVID-19 vaccines to avoid supply disruptions due to sudden changes.
• Validity of issued GMP and GDP certificates until the end of 2023. In the coming months, the GMDP Inspectors Working Group intends to announce the plan for 2024.
• GMP and GDP on-site inspections have already been resumed after being postponed or conducted remotely during the pandemic.

The EMA's Medicines Shortage and Safety Executive Steering Group (MSSG) is collecting the experience gathered with the arrangements and is considering how to incorporate lessons learned to manage drug shortages in the face of future new and emerging health challenges.

Source:

EMA: Phasing out of extraordinary COVID-19 regulatory flexibilities