June 3, 2014

FDA Acts to Harmonize Global Adverse Event Reporting – It’s a small world after all. One of the by-products of globalization is the speed and spread of everything from t-shirts to medical devices.

But everything has its plusses and minuses. When it comes to globalization, a plus for American’s is something like high-quality inexpensive clothes from my haberdasher of choice, J. Crew. On the minus side, we’ve got MERS hitting our shores.

Of course, t-shirts are one thing and safe medical devices and drugs are quite another.

As the FDA has learned, health regulations and standards in one nation do not often translate, figuratively, and literally, to another nation.

Zeroing in on one of the most pressing requirements, FDA is working with the International Conference on Harmonization (ICH) to harmonize global adverse event reporting forms and requirements. It won’t be easy, but the two organizations appear to be off to a good start.

A recent notice in the Federal Register outlines a step forward covering three parts of the globe: the United States, Japan, and the European Union. It does not address other parts of the world.

The core of the new effort is the Periodic Benefit-Risk Evaluation Report (PBRER) draft guidance first issued in 2012, building on guidance issued in 1997 and amended in 2004. PBRER is designed to “promote a consistent approach to periodic postmarket safety reporting among the ICH regions and improve efficiency by reducing the number of reports generated for submission to regulatory bodies.

FDA advises that companies operating in more than one country or region may find it easier to prepare a single PBRER rather than preparing multiple types of reports for multiple regulators.

FDA also outlines some situations where medical device companies must be granted a waiver and other situations where they can apply for a waiver. Existing regulations permit applicants to request waivers of any post-marketing safety reporting requirement, and the information collections associated with those waiver requests are “generally are approved” under existing regulations, FDA says.

Comments are due by June 9th.