Treatment for rare diseases to receive speedy approval
28 julio 2017

July 26th marked the end of the public referendum  from the National Sanitary Surveillance Agency  (Anvisa) regarding the approval of treatment for rare diseases. Rare disesases affect up to 65 out of 100,000 people. The initiative aims at speeding up the process of consent in clinical trials in Brazil and creating a register of rare diseases.

The bill seeks to shorten the period of analyzing petitions and the waiting period for companies to register new drugs. According to the draft bill, companies will be required to present the product to Anvisa within 60 days of the first request in any similar authority around the world. Medication for rare diseases will be sold within a year of registration.

Exceptions set for rare diseases medication should not compromise safety, efficiency and quality of the final product. Following the referendum by Anvisa, the authorities will look into the changes proposed before sending it to the official journal of the federal government.


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