GxP Lifeline Feature Article

FDA Listens to Public Input on Electronic Submission

By Lane Hirning

Issues Related to Electronic Regulatory Environment Discussed

The FDA wants to eventually move to an all-electronic regulatory submission environment. The question is, how?

Representatives of 26 companies and organizations presented their views and six others made public comments at the FDA's public hearing on the viability of a paperless regulatory submission process.

?Let me stress this is a listening exercise for FDA,? said Dr. Janet Woodcock, deputy commissioner for operations of the Food and Drug Administration, at the meeting held on Dec. 18, 2006. The public hearing discussed feasibility issues pertaining to electronic pre-market submissions and issues related to the concept of an electronic platform for the exchange of clinical research information and other regulatory product information.

Over the last decade, the FDA has transformed some aspects of regulatory reporting from paper to electronic means, but the adoption has been voluntary. The FDA has also been collaborating with manufacturers, standard development organizations, and other government agencies to develop data standards and build databases for sharing certain clinical trial information.

Woodcock noted that some sectors, such as the pharmaceutical industry, already submit most of their information electronically, while others don't. ?And therefore, we recognize that whatever we do, we're going to have to take a step-wise approach to implementation, depending on the particular area where we're starting, and that will probably influence how long it would take to get there,? she said.

Incentives for E-Submission

The FDA should provide incentives to help companies embrace electronic submission, said Dr. S. Albert Edwards, director of regulatory affairs at TAP Pharmaceutical Products Inc. ?We must find a common ground to move forward with making e-submissions a requirement and not an option,? he said.

For example, the FDA could reduce the PDUFA ( Prescription Drug User Fee Act) fee for submissions when a submission comes in eCTD (electronic common technical document) format, or the agency could reduce the PDUFA review time for applicable submissions in eCTD format, said Edwards.

The FDA has maintained that receiving information in a consistent electronic format would help the agency make more effective use of important drug information, especially pertaining to safety. Debra Bremer, vice president of development and medical informatics at Pfizer and a representative of the Clinical Research Information Exchange at the public hearing, noted other benefits of an electronic submission environment, such as: lowering product development cost, lowering regulatory review costs, and speeding up delivery of drugs to patients.

The public hearing was attended by representatives of pharmaceutical and medical device companies, contract research organizations, consulting firms, software companies, and nonprofit organizations. Participants discussed some of the issues facing the industry on the road to the FDA's vision of a paperless submission environment. The issues include:

•  Need for a single submission standard.

•  Need for regulatory agency standards harmonization.

•  Need to consolidate multiple FDA guidances (e.g., a CBER guidance for PDF label vs. a CDER guidance for SPL label).

•  Need for infrastructure to receive standardized electronic submissions.

•  Lack of industry resources (time, money, employees with the right skill sets).

•  Variation in terminology as an impediment to effective collaboration.

About the Author
Lane Hirning, a product manager at MasterControl Inc., is a pharmacologist with extensive IT experience in the pharmaceutical industry.

Read about the FDA regulation pertaining to voluntary electronic submission:

White Paper:

21 CFR Part 11 Risk of Non-compliance

White Paper:
21 CFR Part 11 Product Positioning

White Paper:
5 Ways MasterControl Ensures System Compliance with 21 CFR Part 11

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