On Wednesday, March 11, 2020, the World Health Organization declared the spread of the respiratory illnesses caused by the novel coronavirus a pandemic. The impact of COVID-19 is being felt at home, at work, and across the globe.
Pharma and medical device firms are taking precautionary actions that impact day-to-day operations. FDA and other global regulatory agencies are publishing new guidance as well as ceasing international inspections. Here, we summarize the effect of COVID-19 in our community.
What Our Customers Are Doing
We asked our customers what they are doing in response to COVID-19. Everyone is doing much of the same things:
- Travel Restrictions: All non-essential travel banned through April.
- Work from Home: If they have done so already, teams are organizing to work remotely through April.
- Supply Chain: It’s too early to say whether supply chains have been impacted, but so far we are unaware of any effect for the customers we have spoken with.
- Current Business: So far no impact on product sales or business with the exception of how business is being conducted. Companies are leveraging teleconferences and virtual meetings until the travel bans are lifted.
FDA and Global Response
In last week’s edition of the GMP Regulatory Newsletter by Barbara W. Unger, she provided the following links to what the global response has been so far:
- COVID-19 In Vitro Diagnostics: The FR published a final guidance ‘Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency’. The guidance is effective immediately:
- Coronavirus (COVID-19) Update: FDA Issued New Policy to Help Expedite Availability of Diagnostics.
- WHO published Situation Report – 41 ‘Coronavirus Disease 2019 (COVID -19)’.
- India announced restrictions on the export of twenty-six APIs and formulations. We can assume this is due to supply chain disruptions caused by the COVID-19 disease. Reuters reports that this accounts for 10% of all Indian pharmaceutical exports. PharmaCompass also addresses the drug shortage topic.
- The New England Journal of Medicine reports a perspective ‘Responding to Covid-19 — A Once-in-a-Century Pandemic’.
Also, you can read more about FDA’s latest move halting overseas inspections of drugs and devices, citing COVID-19, from the New York Times here.
Image source: Johns Hopkins University & Medicine
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