Only five weeks after the European Commission published the requirements for increasing the safety of medicinal products to protect the EU population (see GMP News from 17 December 2008), on 15 January 2009 the FDA also released a package of three new guidelines, two of them for commenting.
The package includes three guidelines intended to protect the American consumer from unsafe products:
The first guideline is purely directed at the foodstuffs and feedstuffs branch. It goes back to a draft of 10 July 2008 and describes the FDA's current thinking on the voluntary certification by an independent third party.
The second guideline is a draft intended to increase the quality and reliability of test results submitted by importers in order to prove that the product quality fulfils the FDA requirements. The importers are among others advised to have their product tests performed by accredited laboratories, and the type of data and information needed is described. Here, an important point is the restriction that not only the favourable data should be submitted. The guidance is applied to imported products that are not in compliance with the federal laws and regulations or for which an Import Alert has been issued.
The third guideline, a draft as well, represents the first FDA guidance that was issued in the package of innovations for the implementation of Section 913 of the Food and Drug Administration Amendments Act of 2007. The document describes which standards the FDA recommends for the identification of packaging used for prescription medicinal products. The background for this is the facilitated subsequent introduction of a harmonised track-and-trace system.
Both drafts have a commenting period of 90 days.
Detailed information as well as the three guidance documents can be found here.
Dr Robert Eicher
On behalf of the European Compliance Academy (ECA)