Use of SI Units in Regulatory Submission
PhRMA Statement on FDA’s Announcement on Use of SI Units in Regulatory Submissions
Washington, D.C. (October 31, 2013) — Pharmaceutical Research and Manufacturers of America (PhRMA) Vice President of Scientific and Regulatory Affairs Sascha Haverfield, PhD, issued the following statement on the recent announcement by the Food and Drug Administration (FDA) regarding the use of Systeme International (SI) units in regulatory submissions:
“PhRMA welcomes the FDA’s announcement, and urges the Agency to align on the use of SI units in agreement with the international scientific and medical community. As global biopharmaceutical companies seeking to develop medicines for patients around the world, PhRMA’s members recognize the value in providing information to regulatory authorities in a single, internationally-recognized unit of measure.
In 1977, the World Health Organization (WHO) recommended the adoption of SI units by the international scientific and medical community. Leading Health and Regulatory Authorities, such as Australia’s Therapeutic Goods Administration, already require the use of SI units while others, including the European Medicines Agency and Health Canada, have stated that SI Units would be preferred for use in regulatory submissions. An increasing number of publications throughout the world, including American scientific and medical journals, have been using or are switching to SI units as their primary or preferred method for reporting data, including clinical guidelines.
PhRMA supports the FDA’s consideration of SI units as the standard for regulatory submissions and looks forward to working with the Agency on establishing clear recommendations for the use of SI units through the release of draft guidance for industry on this issue for public comment.
PhRMA agrees with the FDA that there may be rare instances, such as in U.S. product labeling, when it would be appropriate to provide both SI units and U.S. Conventional units.”
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research and biotechnology companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested approximately $550 billion in the search for new treatments and cures, including an estimated $48.5 billion in 2012 alone.
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