ANVISA opens public consultation aiming at speeding up the approval of clinical trials for rare diseases
(Client Alert published on 09/23/2022)
On 09/14/2022, ANVISA’s Board of Directors approved a Public Consultation to review the rule that sets forth mandatory pre-submission meetings for clinical trials under the current wording of RCD 205/2017.
The change aims to expedite the progress of research and clinical trials in rare diseases, by waiving the need for a pre-submission meeting before the presentation of trials.
Upon reading her opinion, Director Meiruze Freitas pointed out:
“Since the aforementioned regulation came into force until the present moment, the technical area reports having observed a large number of meetings held merely as a protocol due to the obligation provided for in the said resolution. Additionally, it was found that the holding of these meetings significantly impacts the activities of the area without adding value to the activity carried out”.
The proposal amends the text to make the meeting elective and can be accessed here.
Suggestion forms can be sent between September 28 and October 13, 2022