ANVISA has published a Resolution that could bring more agility in the assessment of clinical trials for rare diseases
On 12/01/2022, ANVISA published RDC 763/2022, revising RDC 205/2017 – which provides the procedures for approval of clinical trials, certification of GMP and marketing approval of new drugs for treatment, diagnosis or prevention of rare diseases.
The amendment made it optional – no longer mandatory – to hold a pre-submission meeting for the evaluation of clinical trials. The focus was on items I and II of Art. 10 of RDC 205/2017. See below the comparison between the old and current text
In line with our Client Alert of 09/23/2022, the change aims to expedite the progress of research and clinical trials in rare diseases.
Upon reading his vote at the 22nd Meeting of the Collegiate Board of Directors, Rapporteur Director Rômison Mota informed: “that the proposed amendment does not constitute a deregulation process, nor does it reduce the criteria that guarantee the safety and quality of studies”. (Minute 01:35:16).
RDC 763/2022 came immediately into force.
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