The National Health Surveillance Agency (Anvisa) approved an update on the rules that regulate clinical research in Brazil. The new standards should make Brazil more attractive for investments in this type of research.
According to the regulatory agency, clinical research encompasses the set of studies carried out with human beings, and the data generated during these studies serve to demonstrate the effectiveness and safety of a medicine that, during the research phase, is considered a product under investigation.
“Clinical studies are one of the central pillars for the registration of new medicines and their arrival on the market,” stated the agency. The proposal was approved by Anvisa’s board of directors this Wednesday (27).
The update to the rules was proposed by the agency’s own technical area and received 240 contributions during the public consultation phase, all of which were analyzed individually by the technical team.
Changes
Among the new rules approved by Anvisa is the possibility of bringing forward the import of investigational medicines for research while the dossier is under analysis. This measure is intended to allow a shorter time between authorization of the research by Anvisa and the actual start of the clinical study.
Another change regulates the use of continuous submission in clinical research, a measure that was used during the Covid-19 pandemic to speed up the evaluation of new medicines and vaccines. With this rule, researchers will be able to present data in stages, allowing Anvisa to begin the evaluation before the information is fully concluded.
The proposal also establishes that clinical research must have a more precise definition of risk categories, study phases and technical requirements. These classifications must be clear for the risk and complexity of clinical trials and investigational medicines.
The new measures also provide for the harmonization of national regulatory practices with standards recommended by the International Council for Harmonization of Technical Requirements for Medicinal Products for Human Use.
According to director Meiruze Freitas, rapporteur of the new resolution, the proposal aims to modernize standards with a focus on reducing bureaucratic obstacles and facilitating the clinical development of medicines, without reducing the technical parameters necessary to prove their safety and effectiveness.
The update will be published in the form of a Collegiate Board Resolution (RDC) with guidelines and procedures and a Normative Instruction (IN) that defines the list of equivalent foreign authorities that can be used to optimize the analyses.
This content was originally published in Anvisa updates clinical research rules; understand the changes on the CNN Brasil website.
Source: CNN Brasil
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