The QMN Weekly Bulletin

Brazil Moves on 2009 Drug Tracking Law; Eyes Streamlined Inspections, Registration

May 3, 2013

Anvisa recently weighed in on the benefits of recognizing international good manufacturing practice (GMP) certificates from drugmakers seeking to register products in the country.

By accepting audits and inspections from peer regulators, Anvisa could potentially reduce its annual inspection workload by 70 percent and ease the registration process for foreign manufacturers, the agency said. Anvisa currently conducts about 600 overseas inspections a year.
The move to accept foreign GMP certificates is still under consideration.

Before Anvisa can implement such a change, however, the national legislature must revise the current law — decree no. 74.094/88 — to simplify registration procedures and reduce red tape. To speed things along in the meantime, the agency recently hired more than 300 inspectors, doubling the previous capacity.

Eliana Silva de Moraes, president of the Brazilian Association of Professionals in Health Surveillance, said she isn’t optimistic the reforms will impact registration times anytime soon. “Unfortunately, the Brazilian agency is very delayed in its activities.”

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