Last Updated on November 15, 2021 by The Health Master
Indian pharma sees considerable relevance to the USFDA guidance on reporting amount of listed drugs and biological products based on technical conformance.
This, according to the regulatory authorities, will bring in a system for submissions for product clearances.
The pharma industry in India which has set up facilities for production in the US sees that this guidance will brings in transparency, accuracy and reliability of the drugs that is sent in for approval from the regulatory authority as it for products not just for the US but all global markets.
The guidance is for formulations, API manufacture, repack, relabel, transfill and positron emission tomography drug production.
This guidance came about after the CARES Act was enacted on March 27, 2020, to aid response efforts and ease the economic impact of the coronavirus disease 2019 (Covid-19).
The CARES Act includes authorities to enhance USFDA’s ability to identify, prevent, and mitigate possible drug shortages by, among other things, improving its visibility into drug supply chains.
Section 3112(e) of the CARES Act added a new section 510(j)(3) to the FD&C Act.
Under section 510(j)(3). Here each manufacturer including repackers and relabelers who registers under section 510 of the FD&C Act with regard to a drug must report to USFDA annually the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.
In sync with the technology adoption, each pharma-biotech manufacturer using the CDER Nextgen portal, should submit reports on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed for commercial distribution. The first time users needed to register and create an account.
The regulatory guidance has indicated that a report will not be considered ready for submission unless, at a minimum, it identifies at least one establishment by Data Universal Numbering System (DUNS) number, ascertains at least one drug by NDC (national drug code) at that establishment and recognizes the business operation performed at that establishment with respect to that drug.
The portal will automatically check the entered DUNS number and NDC against the global regulator’s internal database.
If an entered DUNS number or NDC is not found in the internal USFDA database, that entry will be flagged and a message will display on the screen. If the entry is flagged, the pharma-biotech company can change the entry.
The submission format allows you to provide a single report for multiple establishments. Recognizing that each establishment may perform different business operations with respect to different drugs, instead of identifying the business operations for each NDC, the report is designed to allow establishments to identify the different business operations performed and then identify the specific drugs, by NDC, for which they perform that business operation.
However, as explained in more detail below, you should generally associate an NDC with only a single business operation at each establishment.
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