Report from Brazil - Brazil's regulatory health authority, Anvisa, plans to establish quality requirements for locally produced pharmaceutical excipients, Anvisa told BioPharm International. -

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Report from Brazil
Brazil's regulatory health authority, Anvisa, plans to establish quality requirements for locally produced pharmaceutical excipients, Anvisa told BioPharm International.


BioPharm International
Volume 25, Issue 9, pp. 10-11

Industry reaction

Brazil's pharmaceutical industry professionals are asking whether a pharmaceutical resolution for excipients would affect producers. If approved, established companies would have a period of one year to comply with the new rules.

According to Anvisa, changes would facilitate issuance of authorizations and health licenses, because standards would be put in place and minimum quality requirements needed for guaranteeing the quality of excipients would be absolutely clear. However, Brazil's National Pharmaceutical Laboratories Association (ALANAC) protests: "ALANAC supports any and all regulation initiatives as long as they improve the quality of the feedstock used in producing [pharmaceutical] drugs and [only] if it can stimulate industry competition and the development of local production," said Henrique Uchió Tada, executive technical director for ALANAC.

"Anvisa's public consultation number No. 31/2012 on an RDC resolution for GMPs of pharmaceutical excipients defines that rules will only be applied to the local production, however, most of the excipients used in the pharma industry are imported," complains Tada. According to Tada, the association fears that the real objective of having an RDC—achieving quality assurance—will not be obtained if the rules only apply to excipients produced locally.

Just like the RDC for pharmaceutical drugs, for example, which is valid for local and imported medicaments, "We understand that this proposal...should also be valid for products manufactured abroad," says Tada.

According to the director of ALANAC, similar rules for excipients are not applied by other countries' health authorities as the GMP for pharmaceutical drugs already require that industry suppliers be qualified and guarantees quality controls during all production processes, he adds.

—Hellen Berger is a business writer based in São Paulo, Brazil.


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