Regulatory agility played a crucial role in speeding up the development and approval of medicines and vaccines during the COVID-19 pandemic. The insights gained from this success are valuable for continually strengthening regulatory frameworks, both in emergency and non-emergency situations. IFPMA collaborated with external researchers to gather insights from national regulatory authorities and pharmaceutical companies on the success factors behind regulatory agility, especially ahead of future pandemics.  Overall, agilities have proven beneficial in supporting continuity of regulatory activities and fast authorizations of much-needed quality medicinal products.

Perspectives from national regulatory authorities (NRAs) enable the better integration and use of regulatory agilities. The external research involved interviews with active stakeholders from national regulatory authorities from three countries: Brazil, Ghana, and Japan, to explore their personal views and experiences around regulatory agility. Through this research, a few key lessons on regulatory agility emerged.

Use of reliance and collaboration among NRAs

During the pandemic, NRAs frequently relied on the decisions of other trusted regulatory bodies in their decision-making. The interviewee from the Ghana Food and Drugs Authority (FDA) considered the use of regulatory reliance as one of the biggest successes during the pandemic, and as a helpful practice that continues to be implemented today. Relying on decisions of trusted NRAs allows efficient use of resources and it can free up resources for other value-added activities (i.e., pharmacovigilance).

To tackle the shared health emergency, NRAs intensified communication and collaboration amongst themselves during the pandemic. The interviewee from the Ghana FDA highlighted the agency’s close communication with the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom to discuss observed real-world effects of recently authorized vaccines.

Increased digitalization of working methods

According to all interviewees, the digitization of ways of working was crucial in maintaining continuity of clinical research and regulatory processes during the pandemic, mainly due to restrictions of movement to avoid virus transmission.

Increased digitalization also enabled remote inspections. Interviewees considered remote inspections as efficient methods and were favorable to conducting them in non-emergency times. They said remote inspections should not replace physical inspections, but their implementation should be considered on a case-by-case basis.

All interviewees had positive perceptions of e-labelling. In Japan, this was a common practice even before the pandemic, but it was also adopted in other countries. The interviewee from Ghana noted that this practice was not common in Ghana but believed its adoption would facilitate updating product information and improve patient safety.

Digital tools were also used to conduct clinical trials, allowing so-called “decentralized clinical trials” that facilitated people’s participation in trials and improved recruitment. This is particularly important for diseases with a small patient population.

Digitalization also accelerated use of telemedicine during the pandemic. The interviewee from the Brazilian Health Regulatory Agency (Anvisa) noted that the use of telemedicine during the pandemic allowed virtual prescriptions and dispensing, leading to the enactment of a new Telehealth Act in Brazil in December 2022.

Implementing regulatory agilities moving forward

Boosting the confidence and ability of NRAs to implement regulatory agilities will be critical for future pandemic preparedness. The World Health Organization (WHO) and other international agencies / fora will play an important role in encouraging appropriate use of regulatory agilities. Sharing of best practises among NRAs and capacity-building programs can further support the adoption of agilities, especially for NRAs with limited resources.

As stressed by the interviewee from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, especially in non-emergency times, some NRAs will implement certain agilities that other NRAs will not implement, or will be slower at implementing, due to the different local contexts.

Regulatory agilities will be critical to address the next pandemic. But, already today, NRAs have the opportunity to continue implementing certain agilities, securing efficiencies in regulatory processes, and promptly addressing patients’ needs.

Author

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  Janis Bernat Director, Scientific and Regulatory Affairs j.bernat@ifpma.org