Under the collaboration the United States Pharmacopoeia (USP) and the CPF, which is a private, independent organization responsible for setting quality standards and specifications for medicines in Chile, will develop reference testing materials and exchange of scientific information.
The USP will also work with the CPF, whose standards are legally enforceable in Chile by the National Agency of Medicines (ANAMED), on the adoption or adaption of the United States Pharmacopeia—National Formulary (USP—NF) and the Chilean Pharmacopeia; and the exchange of scientific staff.
Marcela Escobar, CFP president, said: “Chile and the United States share the common goal of improving the quality of medicines in both of our countries, and in the region, and it is our hope that this partnership will help us do just that.”
This was echoed by USP CEO Roger Williams said: “The pharmaceutical industry has grown into a complex global network, making partnerships between official standards setting bodies increasingly important to help ensure the quality of medicines.”
Global quality
The agreement is one of several the USP has signed with regional quality standards organisations this year, beginning with its landmark collaboration accord with the Chinese Pharmacopoeial Convention (ChP) in April.
Since then the non-profit US standards group has signed memoranda or understanding (MoU) with similar groups in Brazil, Russia and India and has also set up a quality standards testing laboratory in Hyderabad, India.
At present USP medicines standards are legally enforceable by the US Food and Drug Administration (FDA) and are also used by manufacturers and regulators in more than 130 countries worldwide.