The impact of COVID-19 on the life sciences industry is both acute and sustained. With an unknown timeline for disruptions, organizations are planning business activities for the short-term with decisions being made weekly and even daily. In periods of rapid change, potential continuity and consistency risks may arise for organizations with unestablished processes and controls.
Our Global Regulatory Affairs team has compiled these helpful ideas for maintaining consistency in your regulatory processes and responsibilities during times of uncertainty.
Tarun Pandotra- Director Regulatory Affairs
Keep a hawk-eye on event-related regulatory changes: Due to the pandemic, the manner in which regulatory filings can be submitted has changed. In certain countries, regulatory authority offices 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, their have been changes to guidelines on reporting adverse events for drugs in development, including those in development to treat COVID-19. Many Regulatory agencies has come out with a directives or notifications for companies managing the Regulatory compliances during the pandemic. Many other countries have given relaxation on submission of administrative documents. 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.
Readjust the Technical Infrastructure: One of the more significant impacts of COVID-19 to the life sciences industry has been the decline in face-to-face interactions. Although the use of virtual programs and channels has been widely accepted, they have not been deployed at the speed and scale that we’ve seen in the last few months.
Virtual channels can be an effective way to reach a remote audience. There may, however, be unique compliance risks and considerations, including reduced visibility and lack of controls in existing systems, policies and processes. Virtual interactions and programs are not exempt from the scrutiny of federal and state governments and manufacturers should closely examine newly established operations to mitigate potential compliance risks.
Taking advantage of expedited development opportunities: In response to COVID-19, many 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 India, the CDSCO has come up with accelerated review of clinical development programs including clinical trials for NCE/NBE or even for re-purpose products. A good regulatory partner can support you to understand how to take advantage of expedited steps.
Managing your Resources: As the situation continues to evolve, businesses must assess how they can use their limited resources efficiently. Re-appraising the balance between in-house capabilities and strategic outsourcing relationships could present invaluable solutions and also opportunities. More specifically, employing strategic outsourced solution providers as needed can provide essential support for strategically managing the current temporary volatility, but also for meeting long-term regulatory needs. The benefits are many; being ready for quality and regulatory compliance speeds time to market, reduces the risk of products being taken off the market, and may even help to increase market share where demand is growing.
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 utilising 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.
GR-CIS’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 and to keep them ahead of competition.
