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Regulatory Focus™ > News Articles > Brazil to Expedite Review and Approval Process, Recognize Foreign Audits and Inspections

Brazil to Expedite Review and Approval Process, Recognize Foreign Audits and Inspections

Posted 25 March 2013 | By Louise Zornoza

Brazil's National Health Surveillance Agency (Anvisa) has announced the adoption of a set of measures intended to modernize and expedite the marketing approval review process for new products subject to its regulatory authority.

The measures are part of the second phase of the Management Agreement agreed with the Ministry of Health.  According to the CEO of Anvisa, Dirceu Barbano, "Our goal is to improve the operational capacity of the agency; modernize the regulatory framework for health; de-bureaucratize processes and focus our actions on managing health risk, and expand cooperation with international agencies to avoid duplication of inspections."

One new measure is the creation of the Electronic Registration System of Medicines, which will start on 15 April 2013, and will apply to new drug applications and should reduce by 40% the analysis time of each request. The goal is to ensure that 100% of the registration processes for new drug evaluation will be done by electronic means by the end of 2013.

Another goal is to reduce the time it takes the agency to review and approve applications from nine months on average to six months  for technological innovation and priority medications for hypertension, diabetes and cancer. The reduction to six months would be consistent with the review time of other agencies such as the US Food and Drug Administration (FDA).

Among the other proposals announced is one allowing Anvisa to recognize audits and inspections carried out by other international agencies and accreditation bodies. This could reduce by 70% the 600 inspections conducted annually by Anvisa in other countries, without compromising public health in Brazil, it said.


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