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Angie Drakulich was editorial director of Pharmaceutical Technology.
USP and the Brazilian National Agency of Sanitary Surveillance are teaming up to develop joint education activities for professionals involved in formulating and using pharmacopeial monograph standards in Brazil.
The US Pharmacopeia (USP) continues to expand its collaboration with drug authorities around the world, this time with Brazil’s regulatory agency. USP and the Brazilian National Agency of Sanitary Surveillance (ANVISA) are teaming up to develop joint education activities for professionals involved in formulating and using pharmacopeial monograph standards in Brazil, according to news releases on the USP website.
“The organizations [are] committed to work together in developing joint education activities for professionals involved in formulating and using pharmacopeial monograph standards,” says a USP release. “The agreement acknowledges that both organizations share common goals for improving public health related to quality medicines through education.”
In addition to drug regulation, ANVISA oversees the Brazilian Pharmacopeia. The agency has offices in São Paulo as well as in the United States. Products manufactured in Brazil and sold into the US market must meet USP standards, which are enforceable by FDA.
According to Dr. Dirceu Barbano, director-president of ANVISA, “With Brazil’s continuing emergence as a center for global pharmaceutical manufacturing, cooperative efforts with organizations like USP will help to refine and strengthen our capabilities in ensuring good quality medicines and their ingredients,” he stated in the USP news release [see Brazil’s perspective in a recent PharmTech blog post].
As part of the educational activities, USP and ANVISA plan to:
Implementation of the agreement will involve leadership from USP’s facility in São Paulo and its global headquarters.
USP has expanded its international reach in recent years through drug-quality partnerships with other national drug authorities, such as that in Russia. The organization runs a program in collaboration with the US Agency for International Development called Promoting the Quality of Medicines (PQM). The program is aimed at helping to ensure the quality, safety, and efficacy of medicines essential to USAID priority diseases, particularly malaria, HIV/AIDS, and tuberculosis.
Of note, Hellen Berger reports on the Brazilian pharmaceutical industry in PharmTech’s September issue. Also in the upcoming September issue: a debate about USP’s international goals.
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