COVID’s Impact on Innovations in Regulatory Affairs

While the impact of COVID-19 was significant in every area of the pharmaceutical sector, some of the most pandemic’s most overlooked impacts were within the regulatory space. From study design to submissions, the virus affected every aspect of drug regulation, from trial design and co-ordination to submission of documents and filings. 

Redesigning clinical trials

The impact of COVID-19 required a more prioritised, rapid vaccine development than has ever been seen before. The need to push through an efficacious, easily manufacturable product to combat COVID affected every aspect of the pharma industry, from drug design to trials to manufacturing and regulatory affairs.

Rapid developments in the regulatory space have been critical in speeding up the clinical trial process. The need to ensure patient safety led to a decentralised, fluid approach to clinical trials, which in turn saw an uptick in ways patient data can be harvested. The urgent need for swift approvals meant that standard procedure was modified or relaxed, with regulatory applications for vaccines approved in less than a week. Overall, regulatory changes made during COVID reduced approval timelines by three to four months. 

The increased speed of the drug development process has also meant that companies need more rapid access to regulatory authorities in order to quickly assess clinical trial development plans or changes. In light of the pandemic, grants of pre-investigational new drug (IND) meetings with the FDA were given in under 30 days, with a reduction in the specificity of non-clinical information needed in order to start studies more quickly.

Another major regulatory change to speed up trial completion was the move towards centralised site clearance. This move away from local approvals of each trial site allowed for quicker approval of sites and subsequently a shortened approval timeline, from months to only days. 

Beyond these changes, regulators became more flexible generally regarding trial design and product approval. A more flexible approach was created regarding product registration, rapid review of trials and auditing. Deadlines were extended where necessary. 

Decentralisation

Novel technologies and the need for social distancing saw the rapid uptake of decentralised trials, often taking place in patients’ homes. These trials have been shown to cost at most the same as traditional trials, but with the added benefits of increased patient engagement and retention, greater data collection and overall faster, more flexible study timelines. 

Scaling up decentralisation while maintaining quality will, however, mean the need for much more rigorous compliance given the diversification of data sources and complexity of large-scale studies. Automation is one solution to this increased need for vigilance, with unmanned data capture through wearable devices and automated reporting critical to ensuring accuracy and completeness of translatable submissions.

The new methods of collecting patient data – from wearables like the Apple Watch to electronic forms such as eCOA – were rapidly accepted and incorporated by regulators, and have helped increase patient safety in trials as well as facilitating a more rapid turnaround in trial completion. 

Regulatory submissions

Shortly after the scale of the pandemic became clear, regulatory authorities began granting Emergency Use Authorizations (EUAs) to COVID treatments. This meant that the onus of creating efficiencies to speed up drug approval fell on regulators. In part, this came from innovations in technology and digitalisation.

Regulatory information management (RIM) technology was used widely to reduce reporting activities through automation and machine learning. Other new approaches to reporting could rapidly expand this speed and efficiency, replacing older models of reporting: adoption of electronic Common Technical Documents, use of electronic product labels, reform to the Certificate of a Pharmaceutical Product procedures, and discarding the need for ‘wet signatures’ on documents would all significantly reduce the current time and onerousness of regulatory reporting for a number of countries and businesses. 

The future of pharma regulation 

The major changes witnessed during the pandemic were created in an extreme situation, and it is without doubt that their extremity will be reduced as the world returns to normal. Nevertheless, many of the lessons learnt during the COVID-19 crisis will continue to be preserved, from swifter pre-IND meeting times to safer drug trial practices. 

Real-world evidence (RWE) will be a major regulatory force in the coming years, with real-time access and analysis of data providing a huge boon to drug research – as long as regulators can fully standardise datasets and analytics, as a lack of careful monitoring can lead to potential risks in the procedure. 

The technology that has been pioneered during the pandemic will continue to grow and develop as COVID-19 recedes into memory. Cloud technology will allow greater connectivity between teams and reduced siloing, on top of speeding up regulatory submission significantly, as soon as it is taken up by regulatory agencies globally. AI, automation and machine learning will speed up document completion and regulatory submission, and move the industry towards higher-value innovations. 

Joshua Neil, Editor
Proventa International