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FDA Globalization Act of 2009 Summary & Status

FDA Globalization Act of 2009 Summary & Status. Edward Arling Quality Compliance Associates, LLC erarli@netzero.com. Sponsored by Congressman John Dingell, 15 th District, Michigan Affects FDA and industry business and regulatory practices, compliance and penalties

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FDA Globalization Act of 2009 Summary & Status

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  1. FDA Globalization Act of 2009Summary & Status Edward Arling Quality Compliance Associates, LLC erarli@netzero.com

  2. Sponsored by Congressman John Dingell, 15th District, Michigan • Affects FDA and industry business and regulatory practices, compliance and penalties • Has impact to Food Safety, Drugs, Cosmetics and Medical Devices • Impending vote by the Senate to approve H.R. # 2749

  3. Industry - requires all facilities producing food that reaches the US to register with FDA. Most registrants to pay fees that would support FDA inspections for both importers and exporters. • Requires risk mitigation plans to be created, subject to FDA review. • FDA – requires a risk based inspection strategy, minimum inspection frequency, enforcement action for non compliance, increases FDA authority for imposing fines and mandating recalls. • Imports – requires foreign manufactures to be certified meeting US standards, allows for third party certification, allows for fast track importation if requirements are met, requires country of origin labeling & disclosure Food Safety

  4. Food standards – requires FDA to issue regulations for production & handling of fresh fruit & vegetables, carbon monoxide treated foods to be labeled, promotes food science & monitoring. • Laboratory Testing – requires testing to be done in accredited laboratories & results sent to FDA • Traceability – requires electronic methodology for FDA tracking including farms & restaurants and standardized lot tracking on shipments. Food Safety

  5. Industry – requires annual registry & fee for all domestic and foreign establishments. • Generic drug firms to pay fee for pre-approval inspections, requires documentation of supply chain, expand labeling requirements and have a risk mitigation program. • FDA – registration fees to support increased inspections&pre-approval foreign inspections • Requires parity for foreign and domestic inspection frequency and significantly enhances regulatory enforcement actions, fines & penalties. Drug and Device Safety

  6. Requires all foreign & domestic manufacturers serving the US to: • register annually • pay registration fees • report adverse events • and comply with US GMP’s. Cosmetic Safety

  7. HR 2749 voted on in the House • Passed on July 30, 2009 • Referred to Senate Committee • Senate Vote • Bill is in Health Education Labor & Pension Committee • Read twice, passed 8/3/09 • Referred to full Senate vote Current Status

  8. Get a copy of HR 2749 & read through it • Be prepared to discuss within your industry, company, professional trade groups • Send any comments to your representative, Senator, Rep. Dingell • ASQ position being formed and headed by Keith Greenaway – ASQ Washington DC representative • Send your comments to your respective FDC Chairperson If Interested in H.R. 2749

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