Local impact
"The main changes [to RDC 17] regard the need to 'Validate Computerized Systems' related with the process of production of
pharmaceutical drugs," says Henrique Tada, technical regulatory manager in Brazil for the National Pharmaceutical Laboratories
Association (Alanac) in Brazil.
According to Tada, the revised GMPs on computer validation and product revision are beneficial because they force pharmaceutical
companies to comply with quality controls in order to supply the local market with high quality drugs. The changes will also
help bring Brazil's pharmaceutical drug manufacture in line with regulatory standards of the most developed countries. (The
revised GMP on validating computer systems used in the production of drugs will involve additional costs for companies and
as a result, will not be enforceable for three years.)
"By complying with international practices, it is easier for domestically based pharmaceutical companies to [perform] export
activities, especially national firms that have been growing steadily," adds Alanac's Tada.
Global harmonization
Other positive changes in the revised GMPs, according to specialists, are related to the global harmonization of procedures
and the sharing of relevant information among international regulatory bodies. According to Anvisa, Brazil regularly collaborates
with other regulatory and surveillance bodies with regard to information-sharing about inspections.
"Brazil, as a member of the Mercosur trade pact, participates actively in activities ... by sharing data and harmonizing procedures
and rules," says Vogler. For example, Anvisa works regularly with the Pan American Network for Drug Regulatory Harmonization
(PANDRH). The network was established in 1999 "to support processes on drug regulatory harmonization," according to the US
Food and Drug Administration website. Participants in PANDRH include national authorities in the Americas, pharmaceutical
interest groups, industry, and academia.
Although the Brazilian pharmaceutical industry does not participate in quality systems and analytical-testing activities as
called for by the International Conference on Harmonization (ICH), notes Tada, Anvisa bases its technical guidelines on those
of ICH.
Hellen Berger is a business writer based in São Paulo, Brazil.
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