FDA launches portal for drug manufacturing volume reporting

Regulatory NewsRegulatory News | 29 October 2021 |  By 

The US Food and Drug Administration (FDA) on Friday launched its new NextGen Portal for reporting manufacturing volume data for drugs and biologics under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), along with two guidances to assist registrants with complying with the reporting requirements.
The portal and associated guidance come more than a year after FDA delayed the collection of drug manufacturing volume data in August 2020. At the time, FDA said the portal would not be ready in time for the 23 September 2020 effective date established by the CARES Act. (RELATED: FDA delays collection of drug manufacturing volume data, Regulatory Focus 26 August 2020)
Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs to include drugs that are “critical to the public health during a public health emergency,” and the active pharmaceutical ingredients of those drugs.
Drugmakers are also required to report manufacturing volume data under Section 3112(e) to FDA, including the “amount of each drug … that was manufactured, prepared, propagated, compounded, or processed … for commercial distribution.”
"The reported data will improve FDA's visibility into the drug supply chain and will help the agency identify, prevent, and mitigate drug shortages," FDA said. The agency notes that reports for calendar year 2020 should be submitted by 15 February 2022 and that reports for calendar year 2021 should be in by 16 May 2022.
The two guidances issued alongside the portal offer recommendations to registrants on the reporting requirements and on the process for submitting reports, as well as technical conformance details for submitting the reports and the data elements that should be included.
Just before the portal's launch, FDA proposed to exempt two categories of products from the reporting requirement: blood and blood components for transfusion and cell and gene therapy products where each lot is used to treat a single patient.
For those products, FDA said its existing visibility into the supply chain offsets the need for manufacturing volume data to mitigate potential shortages. FDA notes that many registered blood establishments already submit information on the amount of blood and blood components for transfusion to the department of Health and Human Services and that manufacturers of cell and gene therapy products where one lot treats a single patient "maintain a highly controlled and secure supply chain from initial request for treatment of a patient to final product delivery to the site where the treatment occurs.


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