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
-
News
13/02/2023
We have advised the first M&A of Pipo Saúde, a digital health and corporate benefits brokerage
We have advised the first M&A of Pipo Saúde, a digital health and corporate benefits brokerage. The company acquired the operation of HRTech Convenia, a benefits brokerage that serves more than 40 clients and covers more than 11,000 lives. The transaction sets Pipo to extend its portfolio to 80,000 lives covered and 220 corporate clients.
-
Client Alert
23/12/2022
Anvisa’s Board of Directors approved the opening of a Public Consultation to propose authorization for the skinny label practice
At the last meeting of 2022, held on December 22, Anvisa’s Board of Directors approved a Public Consultation to amend Resolution-RDC 47/2009 - which sets forth rules for the elaboration, harmonization, updating, publication, and availability of labels of medicines for patients and health care professionals.
-
Client Alert
01/12/2022
Modification in the electronic submission system for Medical Devices
A Anvisa vem trabalhando para centralizar suas rotinas em um único sistema - Solicita. Este mês, o plano de ação envolve a migração de processos da Gerência Geral de Tecnologia de Produtos para Saúde – GGTPS.
