Technical / white paper
Choosing the Right Dimension of Purity
Croda
The FDA is to collaborate with the WHO to build a global surveillance and monitoring system for combating falsified medicines and breaches of the supply chain.
Use of a rapid alert surveillance system will give a clearer insight into the falsified medicine market and global supply chain. Having this data will support the making of more informed decisions and strategies to tackle counterfeits at national, sub-regional and global levels.
The US Food and Drug Administration (FDA) is supporting the project with $960,500 (€688,100) in fiscal 2010 and, subject to fund availability and project performance, up to $847,500 a year for the following three years.
Using this funding the World Health Organization (WHO) will further development of the surveillance system. The FDA will also support the WHO and work with member states to further the project.
Internal work at the WHO is attempting to identify current systems for monitoring counterfeits, such as those used by the industry, or public health areas, for instance infectious diseases. Such a system could be adapted by the WHO and FDA to meet their counterfeit surveillance needs.
Also, the FDA will support WHO technical cooperation with member states to improve data sharing and quality. By working with member states the FDA and WHO will establish the processes, protocols and commitment to collect, contribute, share and use data.
“Active commitment, participation and engagement of national medicine regulatory authorities in any WHO surveillance and monitoring system for counterfeit or falsified drugs is essential”, says the FDA.
Consequently, in addition to cooperating on data, the WHO will work with member states on the implementation, assessment and refinement of the surveillance system. Cooperation will help ensure the surveillance system is of use to national regulators and other stakeholders.
1 comment (Comments are now closed)
Project should include participation by supply chain partners
Counterfeiting is a priority across the phamaceutical supply chain. Serialization and Pedigree requirements and solutions are still evolving. I would like to see participation in these types of projects by Manufacturers, Distributors, Retailers and Consumers. Also, the many standards determining bodies, i.e, GS1, HDMA, etc. should be connected to the effort. There needs to be a holistic approach that ties together the many requirements and regulations into one universal solution with defined standards. Many supply chain partners are looking to 2015 and the California mandate. This effort should be synergistic with state and federal regulations.
Report abuse
Posted by Bill Ricigliano
14 October 2010 | 14h31