Overview:
Amendment of Resolution No. 9 of 2015, which provides for clinical trials with medicines in Brazil, allows, on an emergency and temporary basis, the use of analyses performed by foreign authorities that are members of the ICH.
Introduction
Brazil’s National Health Surveillance Agency (Anvisa) has published a regulation that changes the regulations for conducting clinical trials with medicines in Brazil. The Resolution of the Collegiate Board of Directors (RDC) 573/2021 amends RDC 9, of February 20, 2015, on an emergency and temporary basis.
The measure allows the use of analyses conducted by foreign authorities that are members of the ICH – International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.
The goal is to reduce the waiting time for the Agency’s manifestation in the authorization of new researches.
RESOLUTION RDC 573/2021
Every Clinical Drug Development Dossier (DDCM) involving clinical research with national clinical development, clinical development of biological products (including vaccines), and clinical development in phase I or phase II, has 180 days to be analyzed by Anvisa.
With the rule change, the above cases will have the DDCM analysis performed within 120 calendar days from the date of submission of the first Specific Clinical Trial Dossier (DEEC) to the DDCM.
If the DDCM review is not initiated within this period, the Agency will issue a Document for Importation of Product(s) under investigation for DDCMs that have one or more studies approved by at least one regulatory authority from at least one Founding or Permanent Member Country of the ICH, or by the UK regulatory authority (Medicines and Healthcare Products Regulatory Agency – MHRA), and clinical development be initiated following the relevant ethical approvals
In order to prove the authorization or non-objection to conduct the clinical trial by the authority of any of the above countries, an Official Document issued by the authority or declaration of compliance with the criteria must be submitted.
This rule does not apply to vaccine DDCMs, where clinical development may only be initiated after review and approval from Anvisa and relevant ethical approvals.
The validity of the RDC 573/2021 will automatically cease after 120 days of the Ministry of Health’s recognition that a public health emergency of national importance is no longer configured.
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