Regulatory Focus™ > News Articles > FDA Working with WHO to Build Capabilities, Capacity of Product Surveillance System

FDA Working with WHO to Build Capabilities, Capacity of Product Surveillance System

Posted 22 November 2013 | By Alexander Gaffney, RAC

It was a "blink and you missed it" kind of announcement that the US Food and Drug Administration (FDA) made last week in one of its FDA Voice blog postings.

Buried within a larger post by Commissioner Margaret Hamburg on ensuring the safety of medical products within the Mekong region, Hamburg said that her agency was working with the World Health Organization (WHO) to build an unspecified "global monitoring system to monitor substandard, falsified and counterfeit medicines," and was in the process of working with other countries to develop and test the system.

That was it-no other details about the program's name, its purpose, FDA's partners, or even the development timeline for the project. So Focus went looking for answers.

The program, it turns out, is WHO's Surveillance and Rapid Alert System for Substandard/Spurious/Falsely labeled/Falsified/Counterfeit Medical Products, otherwise known as SSFFC.


The program was first launched in 2011 as a WHO working group intent on taking a more active role in product surveillance to better assure the safety, efficacy and quality of medicinal products. The group includes participants from nearly every country on earth, including five representatives from the US, of which one, Ilisa Bernstein, was from FDA.

"The long-term objective of this project is to significantly improve the quantity, quality and analysis of data on the incidence of SSFFC Medical products through the creation of a global surveillance and monitoring system," the group explains in a leaflet provided by WHO to Focus. "The system is designed to provide stakeholders with a sound and validated basis on which to build and collaborate on strategies for radically reducing the incidence of SSFFC products, identifying the vulnerabilities in supply chains, measuring the harm caused and facilitating the more efficient exchange of information between countries in order to protect patients and consumers."

What's it doing?

The group has met five times in its existence, with the last meeting in July 2013 where it began discussing the specifics of what the mechanisms of a global pharmacovigilance system might look like.

According to the group, national medicine/drug regulatory authorities (NMRAs) are being trained to report incidents to WHO through its structured Rapid Alert Form, which is now available in French and English.

Officials said the system will permit them to observe problems on a global scale, allowing them to share information, identify weaknesses in the supply chain, issue international drug alerts, compare data, and request analyses on "particular areas of interest."

The group has already successfully completed a 10-country, four-month pilot study and 57 member states are reportedly trained on the use of the system. Moving forward, WHO said it is working on increasing the reporting of incidents, expanding the number of languages its reporting forms support, and building its regulatory capacity to better support the program.

The program is supported at WHO by Michael Deats, project manager, and Pernette Bourdillon-Esteve, analyst.

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