Medicines registration requirements during the COVID-19 pandemic

What is it about?

In response to the COVID-19 pandemic, many health authorities around the world offered rather pragmatic licensing and other regulatory requirements to help society and patients to access as fast as possible therapies to combat the virus. These included 1) increased use of digital communication platforms, 2) new fora for top pharma leaders to interact with heath authorities to discuss best way forward, 3) streamlined clinical trials processes, 4) strategies to secure continuous medicines supply, 5) fast tracked regulatory procedures, 6) increased work sharing between agencies, and 7) waiving of administrative bureaucratic steps.

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Why is it important?

The use of flexible regulatory approaches during the pandemic has helped to ensure that medical products have remained available, and that new ones could be effectively researched to address patients' needs. Nonetheless, many of these approaches have been introduced temporarily to mitigate the impact of the pandemic. Our study showed what measure could and were introduced in response to the health crisis. The question that arises is why these pragmatic and beneficial measures should not remain in place even after the pandemic is gone. They did after all serve their purpose for the ultimate benefit of mankind, society, and patients.

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