• Global API Inspection Scheme Continues to Ramp Up, Calls for Additional Members

    An active pharmaceutical ingredient (API) inspection program involving many of the world's premiere global regulatory bodies announced recently its intent to standardize the inspection schemes of the member nations and advance "administrative simplification." The as-yet-unnamed program, which includes the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Australia's Therapeutic Goods Administration (TGA), the World Health Organization (WHO), the...
  • Health Canada: Nearly One-in-ten Trials Inspected Noncompliant

    Health Canada released an updated document Wednesday (28 March) detailing the results of all clinical trial inspections conducted by the agency between 1 April 2004 and 31 March 2011, showing 8% of all clinical trials inspected by Health Canada to be noncompliant with Canadian regulations. The update is the third since the launch of the program, and is intended to "increase awareness of Canadian regulatory requirements within the clinical research community, while mainta...
  • Australia Proposes Ongoing API Inspection Cooperation

    Australia's Therapeutic Goods Administration (TGA) said 2 March that it is working to establish "an ongoing collaboration in international inspection of [Active Pharmaceutical Ingredient (API)] manufacturers and [an] increase in the number of regulators participating" in their good manufacturing practice (GMP) pilot program. TGA noted that this collaboration has resulted in a governing document for the program, which will allow the World Health Organization to become a n...
  • New Bill Looks to Streamline Inspections

    A new bill introduced by Representative Brian Bilbray (R-CA) would rein in regulatory overlap by preventing states from "requiring duplicative inspections" of manufacturing plants. Bilbray's bill, the Science and Technology Regulatory Relief Act of 2012 (H.R. 4044) , prevents states from requiring US Food and Drug Administration-inspected manufacturers to undergo a state-sanctioned inspection. Exceptions are provided if the state receives complaints of unsafe produ...