COVID-19 is now in full swing. Its spread is felt through pressure on world healthcare organizations. Nonetheless, no delay in the regulatory approval of medical device products has been observed so far. Potential delays in regulatory communication and meetings will continue for months. 'Stay At Home' measures and the very limited allowable travel, with no doubt leave a mark on regulatory audits, revisions, and inspections.
Preventive Measures as a Necessity
As one of the solutions, teleconferencing is here for interaction between yours and the person from the FDA. Even though such interactions are more appreciated, telephone conversations should not be underestimated.T-Cons allow the applicant team to go “silent” to debate important issues, gain team agreement, and then return to the discussion and quickly progress the conversation.
There is a great possibility of delaying the review period and the timing of the meeting when it comes to approval. This, of course, will depend on how much the virus impacts the health authority, review teams.
Delays of on-site pre-approval manufacturing site inspections are expected. The FDA has announced suspensions of inspection activities in China and Europe. But the widespread international travel restrictions and border closures will harshly limit, if not entirely, pre-approval and many other routine facility inspections. There is no other option than to regulatory bodies to defer any inspections that can be reasonably deferred. But it remains unclear if regulatory bodies will delay action dates or extend review periods. It is time to think about how to employ a virtual or correspondence-based inspection upon this subject…
The certain limits of on-site pre-approval facility inspections extend to clinical and sponsor inspections. The FDA and other regulatory agencies may rely upon several forms of virtual inspections and audits to ensure that the safety and wellbeing of subjects are protected, to verify the accuracy and reliability of clinical study data, and to assess study compliance with regulations. It is expected the sponsors would be asked to provide information electronically (that would normally be evaluated during an on-site inspection).
With social distancing and travel bans, on-site GxP audits and vendor selection visits have already been impacted. Performance of investigator sites and vendors that would normally be evaluated during an on-site audit will now need to be assessed using alternative methods – virtually.
Turning to new technologies and cloud-based systems
With all of the above priorities coming on the way, technology may be one area that you may consider, but not directly impacted by COVID-19. Even there is a lot of platforms that are cloud-based, most businesses are not prepared for a switch from a paper-based system to electronic.
Online platforms support continued team connection and business continuity. The business should rely on interactive tools with integrated task and document management, instant messaging and meeting options to provide employees with more real-time interactive communication.
Now, more than ever, companies are thinking about moving to cloud-based systems and applications. This is a long-term investment and it will solve a lot of future challenges, like this, we are facing.