It’s a known fact, globalization is affecting our industry. If safe, effective, innovative products are going to reach patients we need to “marry creative international coalitions with cutting-edge investigative tools to continue to provide the consistently high level of safety and quality assurance the public expects- and deserves.”
Because of this, in mid-2011, the FDA launched a Pathway to Global Product Safety and Quality. The FDA’s goal is to accomplish just what’s stated above. The report lays out four building blocks in the approach to achieve safe, global standards:
- FDA will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world
- FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources
- FDA will continue to expand capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities
- FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties
Earlier this month, Mary Lou Valdez, the FDA’s Associate Commissioner for International Programs, released a statement on a new effort for the FDA’s global initiative. In the statement, Valdez refers to the report released last year and comments on how it “identifies the rapid changes regulators face due to globalization and discusses FDA’s efforts to develop an international operating model to ensure global product safety and quality.”
As a result, the Office of International Programs (OIP) is translating many of FDA’s publications to “help the FDA to be a regulatory agency with a truly global reach. To start, translated documents will be available in Arabic, Chinese, French, Portuguese and Spanish, and will be made available at www.FDA.gov/translations.” Currently a Microsoft Excel Worksheet is available that inventories the foreign language translations an document titles available. It’s really a helpful tool to quickly reference the language, product category, and website for the documents language, product category, and website for the documents.
How do you think this new global push will affect regulatory bodies overseas? Do you think the FDA will have an increased regulatory presence and impact because of information being more readily available? Post your comments below.
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