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As we look forward to a ramping up of distribution efforts for the eventual COVID-19 vaccine, there is a very clear need for capacity and FDA-approved cold chain infrastructure. In order to participate in the pharmaceutical supply chain, it is important to obtain relevant FDA approvals for your facilities and processes.

Our partners at the Food and Drug Administration have shared these resources from the FDA’s Center for Biologics Evaluation and Research web portal with us, among them the Coronavirus (COVID-19) | CBER-Regulated Biologics link, BLA Process link, and Vaccine Product Approval Process, to encourage acquiring applicable approvals prior to importation of biologic products.

Coronavirus (COVID-19) | CBER-Regulated Biologics: This webpage provides additional resources to help you determine the next best steps for engaging with CBER, including what regulatory submission is appropriate, what to include in that submission, and how to submit it.

Biologics License Application: The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.

RELATED: Recording: Importing Medical Products

Drug Registration and Listing System (DRLS and eDRLS): Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic and foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Additionally, foreign establishments must identify a U.S. agent and importers at the time of registration.

Vaccine Product Approval Process: Vaccine clinical development follows the same general pathway as for drugs and other biologics. A sponsor who wishes to begin clinical trials with a vaccine must submit an Investigational New Drug application (IND) to FDA. The IND describes the vaccine, its method of manufacture, and quality control tests for release. Also included are information about the vaccine’s safety and ability to elicit a protective immune response (immunogenicity) in animal testing, as well as the proposed clinical protocol for studies in humans.

For any follow-up questions they may be sent to the COVID19FDAImportInquiries@fda.hhs.gov. Additional contact information could be found within the following link –

https://www.fda.gov/industry/import-program-food-and-drug-administration-fda/importing-covid-19-supplies

As preparedness progresses please do not hesitate in reaching out to me, or PAS Kim Prenter as we’d like to continue to contribute in the preparedness efforts by our Import Community where possible.

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