Brazil to Begin Public Comment Period for Proposal Updating Drug Manufacturing Standards
The Brazilian Health Agency will soon begin a 60-day public comment period for a proposal to change the “current good manufacturing practice requirements for medicines,” according to a May 28 report from the Hong Kong Trade Development Council. The proposal will follow the guidelines of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, which covers the U.S., Canada, the European Union, Japan, Australia and South Africa, the report said. The proposal will harmonize Brazilian manufacturing practices with international standards, the report said, and promote “the acceptance of Brazilian medicines in other markets.”
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The agency also began a voluntary pilot program “within the framework of the authorised economic operator programme” for “facilitating the importation of products subject to sanitary surveillance and controls,” according to the HKTDC report and an unofficial translation of a May 29 press release from the agency. The program will "improve the process" for imports that "undergo health surveillance," the press release said, and will increase resources and "reduce deadlines for compliance" with the agency’s import procedures. The press release said that the agency and Brazil’s Federal Revenue Service have 30 days “to form the team that will lead the activities of the pilot project" and that the order authorized the two groups to "issue joint rules within the scope of their competencies."