Governments and businesses around the world continue to respond to the rapidly evolving COVID-19 disease, caused by an outbreak of a novel coronavirus. To date, COVID-19 has caused major professional and personal disruptions, including changes to how businesses function and perform services. Many companies have had to adapt, redeploy, or reduce resources to meet challenges presented by changes in strategy due to the pandemic. Our Global Regulatory Affairs team has compiled these helpful ideas for maintaining consistency in your regulatory processes and responsibilities during times of uncertainty.
- Support your technical infrastructure. As countries around the world have closed doors to offices and public gathering places and initiated stay at home or shelter in place orders, companies have been faced with the very real problem of moving workers from connected office spaces to home environments. In some regions of the world, such as Latin America or parts of Asia Pacific region, it may not be possible to replicate the office technology in individual homes, or would be cost-prohibitive to do so. This, however, does not eliminate the responsibility of pharmaceutical companies to keep providing their marketed products in line with all regulatory requirements. Consider supplementing your technical capabilities using outsource resources who have the appropriate expertise and a stable of connected workers who can provide centralized regulatory operations in your region of need.
- Maximize your resources. Depending on your business situation, you may require long or short term staffing solutions. Companies may choose to redeploy internal resources to teams aggressively pursuing new therapies, now including for COVID-19, leaving other therapies in development with minimal resources. This may call for supplementing your teams in the short term with resources from an outsource regulatory affairs group, which may then go away once the crisis has ended. In other situations, teams may have had to reduce workforce and need a long term solution for those vacant positions. A good regulatory partner can work with you to hire those individuals and either redeploy them to your business, or utilize their skills with other companies.
- Stay on top of event-related regulatory changes. Due to the pandemic, the manner in which regulatory filings can be submitted has changed. In certain regions, regulatory authority offices may have closed or no longer be accepting paper or CD submissions, instead requiring electronic submissions. It is important to identify the new requirements to ensure your submission is accepted. In addition, there have been changes to guidelines on reporting adverse events for drugs in development, including those in development to treat COVID-19. Ensuring that your company is aware of and compliant with all these new guidelines requires a dedicated resource for regulatory intelligence. Partner with an outside firm with expertise in this area to quickly identify areas of concern relevant to your drug.
- Know how to take advantage of expedited development opportunities. In response to COVID-19, the FDA and other regulatory agencies globally have issued guidance around expedited development steps specific to drugs or vaccines in development to treat or prevent COVID-19. For example, in the US the FDA has the CTAP (Coronavirus Treatment Acceleration Program) which employs rolling review, accelerated timelines, hands-on support from FDA review staff and more to expedite the review process. Understanding how to take advantage of expedited steps can be a critical differentiator, which a good regulatory partner can help you with.
- Regularly review your portfolio to assess approvability. No matter what phase of development your compound is in, it is important to consistently review your portfolio to assess your opportunity for approvability and determine any obstacles hindering your progress. As resources are stretched in a global pandemic, it is even more critical to put those resources in the right place. A thorough gap analysis of your portfolio can expose opportunities to accelerate a product utilizing a breakthrough, expedited or rolling submission for your compound, as well as show where putting a compound on the back burner may be advantageous. An expert regulatory affairs consultant can help you complete this review and offer strategic guidance on cost-efficient steps to bring your most promising compounds to market.
PRA’s Global Regulatory Affairs team strategically shortens approval timelines and efficiently gets your products to market and beyond. We are committed to keeping our clients abreast of changes in the regulatory landscape to ensure patients are protected and your goals stay on track.
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