COVID-19 and Health Authorities’ Operational Amendments

The COVID-19 pandemonium demanded Regulatory agencies to set forth certain amendments and measures for smooth functionality of review programs and product approvals. At the same time, the pandemic has encouraged health authorities to take precautionary steps in Regulatory communications and meetings with all the stakeholders. The Regulatory bodies have proposedly altered few of their operations to ensure everyone is safe from this pandemic and at the same time streamline the market-entry of necessary products. Mentioned below are a few of them:

Virtual Audits, Approvals & Inspections: Due to extensive travel restrictions, the FDA has suspended the on-site inspection activities in China, Europe, and across the globe. The Regulatory bodies are likely to defer on-site approvals, inspections & audits, and employ a few virtual or correspondence based inspections, wherever possible. Sponsors are requested to provide information electronically for evaluating the accuracy and reliability of clinical study data adhering to all the restrictions. Also, to assess the conduct of trials without an in-person visit, the sponsors may need to provide access to the electronic Trial Master File (TMF) and other systems. Using either teleconferencing or video conferencing, interactions will be processed with the subject matter experts.

Focus on Teleconferences: The FDA-scheduled face-to-face meetings have been converted to teleconferences. Though the majority of the industry voice the benefits of in-person meetings, the current situation demands virtual meetings. The teleconferences quickly progress the conversations by allowing the sponsor/applicant team to mute on important discussions and gain team consensus.

Partnership for Emergency: Responding to current situations, the life sciences industries and health authorities are working in close partnership with all the stakeholders to accelerate emergency use treatments and to ensure the necessary products quickly enter the market. Recent proactive communication from the FDA to many industries investigating on COVID-19 treatment, stand as the best example.

With all the above transitions from in-person to remote and virtual working environments, it seems technology is the only area unaffected by COVID-19. Utilizing it the most, market entrants and emergency product manufacturers must focus more on walking the Regulatory bodies enhanced procedural best practices. Stay informed. Stay safe. Stay compliant.