28 May 2019
Brazilian Health Agency Proposes New GMPs, Seeks to Facilitate Import Process
The Brazilian Health Agency (ANVISA) will soon kick off a 60-day public comment period on a proposal to amend the current good manufacturing practice requirements for medicines. The proposal is based on the guidelines of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/s), which is the most relevant global forum for the establishment of guidelines and training on pharmaceutical inspection. The main consumer markets for medicines are members of this scheme, including the United States, Canada, the European Union, Japan, Australia and South Africa. The objectives of the GMP proposal include harmonising Brazilian GMPs with international standards, enabling Brazil to accede to PIC/s, and promoting the acceptance of Brazilian medicines in other markets.
Separately, ANVISA has established a voluntary pilot programme within the framework of the authorised economic operator programme aimed at facilitating the importation of products subject to sanitary surveillance and controls. The new pilot includes enhanced resources and shortened deadlines for compliance with the import procedures established by the agency. ANVISA and the Federal Revenue Service (Receita Federal do Brasil) will have about 30 days to put together a team to carry out the activities of the pilot programme.