FDA and EMA Updates on Electronic Submission of Labeling Content: How to Comply?

Designing a product label, which is compliant with the current regulations of both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), is a long and complex process. Pharmaceutical companies are continually managing product-labeling documents such as Summaries of Product Characteristics (SmPCs), Core Data Sheets (CDSs), and Package Inserts (PIs). Often, the same information is duplicated for various dosage forms, product strengths, and presentations, which result in a set of labeling records that are difficult to manage and keep synchronized.

The FDA and EMA have implemented an evolving set of rules for electronic submission of labeling content. The FDA requires that the extensible markup language (XML) labeling content must be submitted in Structured Product Labeling (SPL) format and the EMA requires that pharmaceutical companies must submit product information documents in a Quality Review of Document (QRD) compliant format.

Benefits of Electronic Submission of Labeling Content

Pharmaceutical companies and health authorities have been utilizing eCTD (electronic Common Technical Document) guidance for some time now. Health authorities, FDA and EMA, have announced plans to migrate the paper based submissions to electronic models. The electronic submission requirement is based on the need to standardize the process of data submission, making data more accessible and searchable.

Thus, the regulatory benefits of electronic submission of data to the pharmaceutical industry can be summarized as:

  • Clear and implicit traceability of document creation
  • Working paperless
  • Streamlining a very resource-intensive process
  • Speed-up the time to market

FDA Update

In September 2016, the FDA published new deadlines on electronic submission of labeling content:

Content Format Deadlines
New drug applications (NDAs), Abbreviated NDAs (ANDAs), Biologics License Applications (BLAs), and master files eCTD May 5, 2017
Commercial Investigational New Drug Applications (INDs) eCTD May 5, 2018

After these dates, the pharmaceutical companies will not be allowed to make paper and/or non-eCTD electronic submissions (NeeS).

EMA Update

  • The mandatory use deadline of the periodic safety update report(PSUR) repository started on June 13, 2016.
  • The repository accepts only electronic submissions, that is, eCTD or NeeS format.
  • An XML file as a zip file must be delivered, which contains submission details such as product names, procedure numbers, and information for routing purposes.
  • The zip file for upload must follow a specific file naming convention.

For more insights on designing, creating or implementing product labels, or maintaining labeling records that are compliant with the regulatory requirements of FDA and EMA, attend this Webinar by expert speaker Carolyn Troiano, who has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. With this session, you will also learn to convert Word documents into XML and SPL formats.

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