Keeping up to Date With International Conflict Regs Is a Must for Drugmakers

In many countries, independent experts help make approval decisions on YOUR products. Do you know each country’s policies on conflicts of interest for advisory committee members?

According to recently released guidelines from Australia’s Therapeutic Goods Administration (TGA), drug advisory committee members should disclose any potential conflicts of interest prior to each meeting.

And if a committee member becomes aware of a conflict during a discussion, disclosure should be made immediately, according to the guideline.

Meanwhile, lawmakers here in the U.S. are hoping to use the upcoming Prescription Drug User Fee Act reauthorization as a chance to ease conflict-of-interest standards for FDA advisory panel members. This push comes after the FDA bemoaned the difficulty of finding knowledgeable, qualified members without conflicts.

Tracking conflict-of-interest rules and other regulatory changes around the globe can be a daunting task for any drugmaker. That is unless your company has FDAnews Guide to International Pharma Regulation: 2012 Edition.

This guide gives drugmakers the tools to successfully manage labeling and marketing regulations and ensure they have appropriate anti-counterfeiting measures in place. This book is the go-to source for coverage of the EU, Asia, Latin America, the Middle East, North America and Australia/Pacific regulatory bodies.

Don’t assume the FDA has the same product registration requirements as China’s Ministry of Health or other regulatory agencies — order your copy today!