The Food and Drug Administration has established a pilot program and draft guidance for drug companies to voluntarily submit registration information and their list of pharmaceutical products in an electronic format, the agency said in a draft guidance published today in the Federal Register.
The requested information is fundamental to many processes the agency uses for surveillance for serious drug reactions, inspection of facilities used for drug manufacturing and processing, and monitoring imported drug products inspection, the FDA said.
Submitting the information electronically and in a standard approach will modernize the FDA's processes and improve its timeliness and accuracy, said Jeffrey Shuren, the agency's associate commissioner for policy and planning, said in the posting.
The draft guidance explains the steps for drug companies to transition from submitting the information on paper to using the extensible markup language, or XML, in a standard format called Structured Product Labeling, which would let the FDA process, review and archive the data, the FDA said.
The FDA will require that drug companies use the electronic format beginning June 1, 2009, Shuren said. Before that date, the agency will publish final guidance based on comments during the pilot, he said.
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