The regulatory response to COVID-19 was rapid and coordinated
Rapid reviews, flexible operations and virtual processes by regulatory authorities worldwide during the COVID-19 pandemic have been critical to guide non-pharmaceutical interventions, deploy vaccines and therapeutics, ensure adequate supply of protective equipment and pharmaceutical ingredients, and minimize disruptions to clinical trials for other diseases.Preventing transmission via non-pharmaceutical interventions
Agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and European Commission not only recommended a rapid shift to digital and remote operations for businesses but also set the example by virtualizing reviews and meetings where possible.As supplies of personal protective equipment (PPE) ran short with increasing cases and hospitalizations, revised, harmonized standards and guidelines were quickly published to help ramp up production of masks, hand cleaners, disinfectants and other PPE, including recommendations around the use of 3D printing.
Reliable case identification and contact tracing have remained critical elements of understanding the epidemiology, transmission and priority areas. Timely review and issuance of emergency use authorizations (EUAs) for diagnostic tests by the FDA began in February with the Centers for Disease Control and Prevention (CDC) diagnostic panel and have continued throughout the year. In keeping with the need to keep the population at home and avoid risk of infection, notable approvals include firsts for patient-collected samples at home in April, point-of-care serology antibody test in September and at-home self-test in November.
In Europe, the EC encouraged a common testing approach, which was outlined in recommendations published in September. The Commission also mobilized large amounts of financing for testing throughout the EU.
Getting therapeutics approved and in the market
The speed at which COVID-19 treatments have been investigated (both formally and informally) has also been unprecedented, supported by efficient, rapid regulatory reviews. As early as May 2020, the FDA had published new guidance to improve efficiencies in the application submission process to initiate studies for new drugs and biological products.According to the website for the FDA’s emergency program for possible COVID-19 therapies, the Coronavirus Treatment Acceleration Program (CTAP), as of 16 February, there were more than 600 drug development programs in planning stages, more than 420 trials that had been reviewed by the FDA, eight COVID-19 treatments authorized for emergency use and one treatment currently approved by the FDA for use in COVID-19.
In a joint statement endorsed by the EMA, international medicines regulators described the key characteristics of clinical trials that are most likely to generate the conclusive evidence needed to enable the accelerated approval of potential treatments. The EMA also contributed to an internationally generated report regarding the acceptable primary endpoints in clinical trials conducted for the development of COVID-19 treatments, with the aim of facilitating rapid and consistent implementation of future clinical trials for COVID-19 medicines worldwide. Global collaborations such as this have been crucial to accelerate the development, production and equitable access of COVID-19 treatments.
Continuing to develop and manufacture critically needed drugs for other diseases
Unfortunately, the pandemic has also affected the development of drugs across the industry, suspending many trials. However, using published regulatory guidance, clinical trials have been able to continue with adjustments to conditions or protocols while still adhering to regulations and ensuring the safety of patients and study staff. Because of this guidance and adaptations to trial conduct, drug companies submitted applications in 2020 for approval of treatments and diagnostics for a range of diseases including breast cancer, Alzheimer’s disease, HIV and many more.Another concern has been shortages of medications for other diseases because of disruptions in supply chains, shutdowns of manufacturing facilities and diversion of resources to address COVID-19 manufacturing needs. Regulatory agencies also acted quickly to prioritize affected drugs and biological products for remedial actions—to maximize the availability of critical drugs for patients.
Adapting to the situation
As the pandemic continues to impact the globe, governments, regulatory agencies, pharma companies and manufacturers have adapted to the situation to develop, test, review, manufacture and distribute needed vaccines and therapeutics for COVID-19 and other critical diseases.Read our blog series to learn more about the regulatory responses to COVID-19, including those discussed here as well as protecting personal data privacy while facilitating digital contact tracing; review and approval of other drugs; maintaining a safe, sufficient, accessible supply of substances of human origin (SoHO); other collaborative efforts; and the need to remain resilient for future outbreaks.
Monia Tumminello is a manager with Cortellis Regulatory Intelligence and Jaime Polychrones is a medical writer with Cortellis Regulatory Intelligence