China eCTD Requirements – Center for Drug Evaluation (CDE) Guidelines - Celegence

What are Ad/Promo Submissions?

The promotional labeling and advertising materials, together known as promotional materials for human prescription drug products, are to be submitted to the FDA (Food and Drug Administration) once the drug product has been approved by the FDA. These submissions are processed on a 2253 form, which is the Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use. Form 2253 is required for approved new drug applications (NDAs), Abbreviated New Drug Application (ANDAs), Biologic Licensing Applications (BLAs), and the submissions are made to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER). These submissions are essential for every pharmaceutical company as it aids in marketing their pharmaceutical drug products approved by the FDA.

Promotional labeling is different than the FDA regulatory labeling requirements and focuses on promoting drug products. There are various types of promotional materials that include videos, websites, telephone communications, print ads, television ads, social media ads, and much more.

The FDA currently receives various types of advertising and promotional submissions either in eCTD format, or in a non-eCTD format that includes Form FDA 2253 submissions, Pre-submission of promotional materials for Accelerated Approval Products (Subpart H and E), promotional materials for Advisory comments, Resubmissions, General correspondence, Amendments, Withdrawal requests, Response to warning letters, Response to Information requests, Reference documents, and Complaints.

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How are Ad/Promo Submissions Completed?

eCTD Submissions are submitted electronically using publishing tools, whereas non-eCTD submissions are submitted via paper or CDs. The instructions for processing form 2253 can be accessed at the link below:https://www.fda.gov/media/132152/download

Non-eCTD Submissions: This includes submitting all promotional materials either as a hard copy or in CD format. For a CD submission, as soon as 2253 is submission-ready, it requires printing two copies of the 2253 and the labels associated with the submission. This is followed by the burning of the respective folders on to a CD or DVD based on the file size, and all these are put together inside a blue box file and mailed to the OPDP department of the FDA. This process has additional steps if there is multiple submissions. This process involves printing many copies paper and utilizing a lot of supplies, which ultimately generates paper wastage and increases pollution leading to ecological damage.

eCTD Submissions: All eCTD submissions are mandated to be submitted in eCTD format from June 2021 onwards. Electronic submissions can be submitted using the FDA’s recommended publishing tools. The most common types of submissions include Form FDA 2253 and pre-submission for accelerated approval products. The submissions are built according to the specifications of the eCTD guidance document. As soon as the submission is ready, the files are pulled on to the respective eCTD structure on the publishing tool from the document management system where the entire submission is processed, QC’d, compiled, validated, and published via the Electronic Submissions Gateway (ESG).

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Which eCTD Submission Seems Better?

It is now time to get started. eCTD submissions seem to be far better than non-eCTD submissions. Perhaps, the transitioning from manual to electronic versions of processing submissions is a bit complicated initially, but in the long run, it saves a lot of time and energy. Switching to electronic submissions can help lower the administrative costs, reduces paper wastage, and can increase productivity. As this process is automated, reviews become easier, space is saved (especially for paper dossiers which are lengthy), and errors are minimized. It is also useful for quick navigation through the documents and improves the entire life cycle management.

Advantages Disadvantages
Paper/CD
Ease of compiling the OPDP submission and fast turnaround time. Manual compilation.
The submission specialist is responsible for maintaining and keeping track of the supplies required for compilation. Manual QC of papers and CDs.
Tracking and claiming the shipments sent to OPDP is hassle-free. Submissions require physical copies of the 2253 form, promotional materials, and PI for paper and compilation on CDs for CD submissions.
The budget needed for companies to sustain logistics related to Ad/Promo Operations is economical. Environmentally unfriendly.
It is more convenient to establish Ad/Promo operations in smaller companies that cannot afford expensive eCTD systems and extra employees. Possible chance of shipments being missed especially during severe weather conditions
No record of archival for the submission packages mailed to OPDP.
No traceability of errors in the process
eCTD
All the submission components are electronic versions of submission materials. Possible chance of error using an incorrect electronic version of the submission.
Submission metadata and promotional material metadata must be filled with respect to the 2253 form in order to compile a submission/sequence. Possible chance of entering incorrect metadata for submission.
The compiled submission must be validated against the eCTD validation tool to avoid any significant errors. Any significant errors not caught in QC might lead to technical rejection of the submission when submitted via the ESG (Electronic Submissions Gateway).
The submission must be QC’d as per electronic standards of the FDA against the company-specific checklist. Expensive for smaller companies to buy and maintain eCTD systems for Ad/Promo operations.
The process is eco-friendly. More work is required for companies that have a high volume of Ad/Promo submissions.
Submission compilation and QC must be performed by experts experienced in eCTD systems and FDA OPDP regulations.
A large budget should be allocated to Ad/Promo operations when compared to paper/CD submissions.
• Dedicated IT professionals are required to support and maintain eCTD systems.
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EU MDR - Celegence Life Science

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Make sure you and your business are compliant with the new EU MDR. Get our 23 page checklist for actionable technical documentation requirements.

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Mandatory Transition of Ad/Promo Submissions by June 2021

The faster you can adapt to the new technology, the quicker your organization will experience boosts in productivity and process efficiency. Before implementing eCTD submissions, various scenarios must be discussed regarding publishing submissions for Ad/Promo. Building test submissions plays a crucial role in identifying errors and other issues. The tool’s validation report helps to identify the errors, address the challenges, and resolve them quickly. All companies are currently adding Ad/Promo operations to their existing regulatory operations team, or they are outsourcing it to regulatory publishing CROs. Until last year, companies were able to submit via paper or cd format. Now, all companies are shifting to eCTD format because of the mandatory transition of Ad/Promo submissions by June 2021.

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Advertising and Promotional (Ad/Promo) Submissions to the OPDP

Celegence is a provider of services and solutions to support the Life Sciences industry with regulatory affairs operations and strategy. Celegence supports clients with processing and compiling Advertising and Promotional (Ad/Promo) submissions to the OPDP division of the FDA as per the client’s specifications, and the FDA regulations to ensure compliance and support the transition from paper to eCTD format. We also offer end-to-end Ad/Promo submission management and an established business processes for Ad/Promo operations.

For more information, reach out to info@celegence.com or contact us online now.