Overview:
Anvisa has defined a specific subject code for petitions related to Call Notice 2/2020.
On Thursday (1/30), Anvisa published Call Notice 2/2020 , aimed at requesting information on similar drugs registered in the country, but which have not yet been adapted to the rules of the Collegiate Board Resolution (DRC) 134/2003 . RDC 134/2003 establishes standards for the suitability of similar drugs, requiring companies to send proof of safety and efficacy or interchangeability with the reference drugs.
Bio-similar specific subject code:
In order to simplify the fulfillment of Call Notice 2/2020 , Anvisa created a specific subject code for petitions. This is the code ‘11551 – Amendment – Notice of Adequacy to RDC 134/2003’.
The code should be used for the cases covered by the requirements of item 2 of Notice 2/2020, in relation to the target audience. In these situations, the company must file within 60 days, counted from the publication of the notice, specific addition to the registration process, with the relevant documents.
Bio-similar Regulatory Requirements:
Companies must comply with certain requirements, such as having bioequivalence, pharmaceutical equivalence and / or bio-exemption studies filed at the Agency until the date of publication of the Public Notice and not having the renewed application rejected on appeal. In addition, it is essential that the studies have been carried out in accordance with the rules of RDC 134/2003.
Conclusion:
The information will be evaluated by the Agency and similar drugs suitable for the Resolution that fulfill all the conditions of the Public Notice will be included in the list of interchangeable similar drugs.
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