Mutual Reliance Blossoming Among FDA, EMA, Other Inspectorates / FDA, EMA and other agencies are increasingly relying on each others' inspection results in an effort to spread their inspectional resources throughout the furthest corners of the globe. Inspection coordination remains somewhat ad hoc, with EMA keeping a spreadsheet for some and PIC/S enabling others. / “The Gold Sheet” January 2012

Pharmaceutical Industry Adopting QbD for Analytical Testing / Both the pharmaceutical industry and regulators are exploring new QbD approaches for analytical method development. FDA regulators have approved analytical QbD submissions and say that regulatory relief will be granted to those firms that use this approach, while the EU has been less accepting. / “The Gold Sheet” January 2012

Implementing Minor Changes is Hard to Do Under Variations Regulation / European generic drug makers say that it is difficult to implement Type IA changes under the variations regulation because of all the paperwork involved in submitting these changes to competent authorities. A 26 percent fee hike in filing variations is also making it more costly and difficult for manufacturers to justify making changes. / “The Gold Sheet” January 2012

ICH Impurity Thresholds are Unrealistic for Antibiotics / EMA's proposal to apply the same ICH impurity limits to antibiotics produced by fermentation and semi-synthetic methods as new drug substances is considered unrealistic, and could result in market withdrawals of these products. / “The Gold Sheet” January 2012

USP To Bring Global Perspective To Track And Trace Discussion / The U.S. Pharmacopeial Convention released a framework Jan. 4 for instituting supply chain security measures and plans a May workshop with speakers from other countries to discuss their programs for tracking drug components and products through distribution channels. / “The Gold Sheet” January 2012

Results from Last Month's "The Gold Sheet" Poll / Last month, we asked you how strong are your quality cultures, based on a five-point scale that Novartis uses. Now the results are. / “The Gold Sheet” January 2012

19^th Annual Euro-Biotech Partnering Summit / Publisher’s Spotlight: Join us in Paris, France from May 30-June 1, 2012 for the 19th Annual Euro-Biotech Partnering Summit. This year’s theme is Changing the Business Model: Drawing on Global Examples of Innovation to Find New Products and Maximize Efficiency. / “The Gold Sheet” January 2012

9^th Annual Pharmaceutical Strategic Outlook (PSO) Conference, April 11-13, 2012 / Join us at PSO 2012 where we will delve into the top issues affecting the pharma industry. Experience a dynamic three days of networking and discussion - with a personal and interactive setting, in-depth on-stage interviews, thought-provoking panels, one-on-one partnering meetings and innovative company presentations by carefully selected biotech companies. / “The Gold Sheet” January 2012