Regulatory Focus™ > News Articles > Brazil's Anvisa to Implement Programs Improving Patient Access to Experimental Drugs

Brazil's Anvisa to Implement Programs Improving Patient Access to Experimental Drugs

Posted 15 August 2013 | By Louise Zornoza

Brazil's National Agency for Sanitary Surveillance (Anvisa) published a new regulation (Resolution RDC 38/2013) on 13 August 2013 that sets forth several pathways for providing patients access to drugs before they are approved.

The first is a Compassionate Use program framework, in which Anvisa provides authorization for the provision, under a public welfare program, of a promising access to a new drug without agency registration for the treatment of rare and serious diseases.  Unregistered drugs may also be imported from abroad under Compassionate Use.

The second is an Expanded Access program, which makes available promising new drugs that are not yet registered with Anvisa or commercially available in Brazil, but that are in or have completed Phase 3 clinical study. This program is geared towards patients with severe debilitating or life threatening diseases for which there is no satisfactory alternative therapy.

The third program is the Post Study Drug Supply Program, which formalizes the customary practice of sponsors to provide free drugs to the study volunteers who benefited from the drug during clinical development.
Requests for Anvisa approval of expanded access and compassionate use programs will be evaluated by the agency according to the severity and stage of the disease and the absence of satisfactory alternative therapy in the country.

 

Anivsa: Resolution on Expanded Access Programs

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