In the wake of COVID-19, the global health industry has been put to the test. Age-old protocols were threatened as social distancing and illness threatened to wreak havoc on companies. While nearly all industries have had to work to adapt to the rapidly-spreading illness, the global health field has had their work cut out for them. Currently, many of those companies are experiencing or anticipating work stoppages due to COVID-19.
1. RA & Quality Control: Document Authentication Backlog
Document authentication is an often overlooked component of regulatory affairs in the global trade life cycle. In mid-March, embassies began to close, or run on minimal staffing. Now, this created an immense problem for regulated goods headed to Non-Hague countries, as embassy legalization is necessary to export and sell in those destinations. While finalized products face this issue, products on an earlier bend of the quality control cycle risk developmental delays. With social distancing in place and many employees now remote, review cycles and timelines for products have been impacted.
2. FDA Overriding Supply Chain Security Requirements
With the intent of combatting COVID-19 and related illnesses, the FDA issued guidance detailing exclusions and exemptions to certain requirements under the Drug Supply Chain Security Act, due to the urgency of COVID-19 by the end of April.
To keep things moving forward, the FDA has been doing all it can to ensure Med/BioTech companies are able to respond to the rapidly evolving battle against COVID. The FDA published a nine page guidelines document on COVID, and explained their exemptions under the DSCSA. Download the full guidelines from FDA.
“Under the DSCSA, specific activities are automatically excluded from certain DSCSA requirements upon the declaration of a public health emergency.”
FDA
3. EU MDR Postponed to May 2021
The most massive impact on the industry has been the postponement of the EU’s Medical Device Regulations, introduced in 2017 and originally set to launch in May of 2020. With Notified Bodies already overwhelmed, the delays brought on by COVID forced a delay into 2021.