By December 2020, several potential covid-19 vaccines were showing promise in clinical trials. And by the middle of 2021, a vaccine was available to the public. Very few people had been optimistic that such a feat could be achieved. In many ways, it was a perfect storm. The fast development of covid-19 vaccines benefited from years of previous research on related viruses and vaccine trials that used mRNA. It’s said the research matured at just the right time, and that mRNA technology would not have been ready even five years ago.

But the time-consuming part of bringing a vaccine to market is not necessarily the initial research, but everything that follows, including rigorous clinical trial testing, regulatory application approval, manufacturing and communication. On average, this takes just shy of a decade. But advanced digital tools and regulatory levers for faster approvals were at the ready, giving stakeholders the means to move at—relatively—lightspeed. The process was a whirlwind that is likely to affect regulatory practices for years to come, prompting new mindsets and applications of tools to the wider biotherapeutic landscape.

We asked experts in regions with advanced regulatory systems—the UK, the US, the EU and Japan—what happened and what changes are likely to stick. The most significant takeaways are highlighted in this report.

Notable findings include:

• Co-operation and collaboration between the industry, regulators, governments, clinical investigators, academic scientists and non-government organisations (NGOs) has been unprecedented. For many, this was seen as the most effective tool in bringing the covid-19 vaccine to market so quickly. This could set the stage for further alignment in decision-making, de-risking for research and development (R&D), and establishing plans for programmes and standards across the biotherapeutic regulatory landscape. But for this to carry forward successfully, elements of nationalism and competition need to be revisited.

• Rolling reviews and Emergency Use Authorisation (EUA) were essential tools for speed. Coupled with an all-hands-on-deck mindset from industry and regulators, processes that typically took years instead took months, and those that took months accelerated into weeks. Post-pandemic, our experts think a middle ground can be found. Where the balance lies, of course, may be conditional for years to come. Some believe that such measures may be best for crisis situations, but others feel that these efficiencies can trickle down to the wider pool of biotherapeutic therapies.

 • Digital tools—onwards and upwards. Digital tools adopted in the pharmaceutical sector have soared. Decentralised and remote clinical trials, remote inspections, digital submissions to regulators, and more data-driven discovery were always likely to be part of the future, but the pandemic sped up that eventuality. Many of these tools were already there for the taking but underutilised due to concerns about introducing risk to process and regulatory approval. There’s little turning back now. Many regulators have been quick to offer guidance in these areas and show willingness to engage with industry to expand on them as needed.

 • Too often, manufacturing is an afterthought. The high demand for drug manufacturing, and general shortfall of manufacturers available to produce new or additional drugs, means that, even if the rest of the pharmaceutical ecosystem sped up drug development and approvals, a bottleneck could slow time to market. Covid-19 put a spotlight on the issue, as well as supply chain challenges, and the need for flexible manufacturing procedures to allow for more parallel planning with drug development. These needs may help speed the adoption of continuous manufacturing processes, which offer more flexibility than batch manufacturing and faster delivery times.

• Global standards are in the pipeline. Operating in multiple jurisdictions often introduces all manner of complications from a compliance and regulatory perspective, as well as data standards. Consortiums of global regulators and industry bodies have long tried to harmonise standards to ease the increasing number of global R&D initiatives and streamline applications for marketing approval. Progress was slow, but it helped lay the groundwork for the global collaborations that came to light during the pandemic. This momentum, stakeholders say, has continued, helping them carry on developing for the future benefit of global efficiencies.