The US Food and Drug Administration (FDA) announced it has trained more than 1,600 regulatory professionals in China on US safety standards, which It says is helping to develop an "infrastructure that better ensures product safety." In its 5 April website posting, FDA's China Offices Focus on Product Safety , FDA notes their 13-person staff in China "represents a new era in cooperation between the United States and China on the safety of food and medical products." "...

A new report from the Institute of Medicine (IOM) concludes the US Food and Drug Administration (FDA) needs to make investments into advancing the regulatory capacity of developing low- and middle-income nations in order to secure the pharmaceutical supply chain and safeguard the American public. The report, Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad , recommends 13 steps FDA and other regulatory bodies can take in the next five ...

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 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'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...

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...