Brazil's Anvisa Addressing Drug Approval Priorities
Posted 05 October 2012 | By
Brazil's national regulatory authority, Anvisa, announced on 4 October a number of steps it has implemented to address the priority public health needs of the country, part of a multi-year reorganization aimed at better addressing the health and economic development needs of the country and its population.
One of the measures it has implemented is the establishment of an expedited review and approval procedure for medicines deemed to be priority treatments for use by the national health service (SUS). Drugs eligible for the expedited procedure include generics as well as innovative new drugs.
Another measure is its review of its regulatory framework. It said it has made a number of changes where necessary, including simplifying the registration process and entering into information exchange agreements on manufacturing site inspections with counterpart regulatory agencies in a number of countries, such as Argentina, Australia, Canada, France, the UK and the US.
The agency is also in the process of implementing an electronic application filing process, due to launch later this year, which will further speed up product reviews.
Anvisa also provided a review of its achievements over the last three years. Between 2009 and 2012, it said, 214 applications for registration of new molecules were filed with Anvisa. Of these, 87% have been reviewed by the agency and 62% (133 requests) have had a final determination (acceptance, rejection or termination of proceedings on request) issued by the agency. Twenty-five percent (54 requests) are currently under review, while only 13% (27 applications ) are awaiting the initiation of review. The oldest application without response from Anvisa was filed in March of this year.
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