As the pharmaceutical industry pushes towards full DSCSA compliance this November, stakeholders and the FDA have made efforts to streamline and improve processes to ensure the security and integrity of the drug supply chain. One significant tool created by the FDA is the enhanced CDER NextGen Portal, which facilitates communication regarding
- FDA 3911 submissions
- suspect drug investigations
- Waiver Exception & Exemption (WEE) submissions.
Our serialization compliance team at Two Labs has received several questions about whether manufacturers should register for the portal. In this article, we’ll explore the portal’s potential use cases, weigh the pros and cons of registration, and address lingering questions and concerns within the industry.
FDA’s Push for the CDER NextGen Portal
During the FDA/PDG joint public meeting in June 2024, the FDA reiterated their desire for manufacturers to use the CDER NextGen Portal to report and manage suspect and illegitimate products within the pharmaceutical supply chain and during recall scenarios. If a product is suspected of being counterfeit, adulterated, stolen, or otherwise deemed suspicious, the portal provides a means for stakeholders to report and investigate such incidents. This reporting helps track and trace suspect products, facilitating rapid response actions to mitigate potential risks to public health. The portal also gives the FDA a more direct point of contact for DSCSA issues, addressing past problems and finding the correct contact at manufacturers.
Source: https://cdernextgenportal.fda.gov
Benefits of Using the CDER NextGen Portal
Utilizing the portal for communications regarding suspect and illegitimate products instead of managing these scenarios via email could serve as a singular repository for FDA communications, helping to document details such as timestamps and user submissions. Additionally, the portal handles large files more efficiently than email. Illegitimate products must be reported to the FDA through FDA Form 3911 and to trading partners. While the portal supports the submission of FDA Form 3911, it does not include trading partner communications, which could present challenges when tracking tasks related to reporting illegitimate products. If a manufacturer chooses not to use the portal, the FDA Form 3911 can still be submitted via email to the FDA’s DSCSA mailbox.
Challenges in Adopting the CDER NextGen Portal
A challenge to consider is determining which parties need access to the portal. Manufacturers typically have accounts on the CDER platform for their regulatory departments, but these teams may need to contain the correct contacts to respond to DSCSA issues. Additional access would likely be necessary for those managing DSCSA matters. Furthermore, manufacturers need to determine whether submitting reports through the portal would bypass internal documentation practices and interfere with any internal approvals that need to occur before replying to the agency.
As the November 2024 deadline approaches, many manufacturers are deciding whether to apply for an FDA WEE. The FDA has stated that manufacturers should apply for a WEE for products without serialized data before November 27, 2024. Some wholesalers have pushed this deadline up to as early as August and have already begun asking about the status of WEE applications for any products that do not have data. The agency encourages manufacturers to submit any WEE through the CDER NextGen portal, citing the above-mentioned benefits.
Is the CDER NextGen Portal Right for You?
The CDER NextGen Portal is a centralized system that enables stakeholders to report and manage suspect or illegitimate products and efficiently coordinate recall efforts with the FDA. This functionality could help safeguard the integrity of the pharmaceutical supply chain and ensure prompt actions to protect public health by preventing the distribution of potentially harmful products. However, it is still being determined whether the FDA will consistently utilize the portal for all communications, potentially contributing to challenges with managing multiple communication types. The adoption rate of the portal among manufacturers has yet to be shared, but since its use is not required, most manufacturers still need to use it. Whether a manufacturer would want to be an early adopter of the portal and whether utilizing it could invite more interaction with the agency.
More information about the portal, including how to register, can be found here.