-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
The US FDA launched a new NextGen portal on October 29 to report production data of pharmaceuticals and biological products under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), and subsequently issued two guidelines Help registrants comply with regulations and reporting requirements
.
The portal and related guidelines were released after the FDA delayed the collection of drug production data for more than a year in August 2020
.
At that time, the FDA stated that the portal could not be ready by September 23, 2020, as required by the bill
Section 3112 of the CARES Act establishes new reporting requirements for pharmaceutical manufacturers to improve response to drug shortages, including expanding the reporting requirements for shortages of life-saving drugs to include “critical to public health in a public health emergency "Drugs, and the raw materials for these drugs
.
"
The bill also requires pharmaceutical manufacturers to report production data to the FDA under Section 3112(e), including “the production volume of each drug produced, prepared, cultivated, formulated, or processed for commercial distribution
.
” The bill also allows the FDA to request electronic format Submit this information and give the Minister of Health discretion to waive some or all of the production data reporting requirements for biological products
The FDA stated that “the reported data will increase the FDA’s visibility into the drug supply chain and will help the FDA identify, prevent and alleviate drug shortages
.
” The FDA pointed out that the 2020 calendar year report should be submitted by February 15, 2022.
The two guidelines provide registrants with recommendations on reporting requirements and the process of submitting reports, as well as the technical consistency details of the submission of reports and the data elements that should be included
.
The FDA proposes to exempt two types of products from the reporting requirements: blood and blood components used for blood transfusion, and each batch of cell and gene therapy products used to treat a single patient
