November 2020: Brazil Regulatory Update

All the services including registering, approving, or editing the studies on the current platform (ReBEC) are temporarily suspended, due to the data migration process from the current platform to Brazil’s new platform ‘OpenRebec’ from 19 November 2020 to 23 November 2020.

OpenRebec brings new and improved features and is fully compliant with the standards of the International Committee of Medical Journal Editors (ICMJE) and the International Clinical Trials Registry Platform (ICTRP), preserving Brazil’s place among members of the WHO primary registry network, with recognition of the registration on the Brazilian platform by the main journals in the world.

April 2020: Comparing Guidances on COVID-19 Disruptions of International Clinical Trials

On April 08, 2020, Ropes & Gray published a document comparing the guidance documents related to COVID-19, its impact on and additional requirements for conducting the clinical trials. The guidance documents involved are issued by the European Medicines Agency (“EMA”), the French National Agency for Medicines and Health Products Safety (“ANSM”), the German Federal Ministry of Health (“BfArM”), the Italian Medicines Agency (“AIFA”), the Spanish Agency for Medicines and Health Products (“AEMPS”)Switzerland’s Swissmedic and swissethics, the Australian Department of Health, the Brazilian Health Regulatory Agency (“ANVISA”)Health Canada, and Singapore Health Sciences Authority (“HSA”).

Earlier, on April 02, 2020, a comparative chart was published summarizing the guidance documents issued by FDA, EMA, MHRA and PMDA.

The comparisons include initiating a new clinical trial, continuing a clinical trial, any changes (amendments) to a clinical trial, informed consent changes, study visits, COVID-19 screening procedures, monitoring
activities, investigational product distribution and study reporting.

July 2018: Brazil Regulatory Updates

As per ResolutionNo466 and OSNo001/2013, Brazil has a centralized registration process for ethics committee (ECs) and requires institutional level EC approval for each trial site. The National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa) (CONEP) serves as the central body that reports to the National Health Council (NHC) (Conselho Nacional de Saúde (CNS)), the advisory body for the Ministry of Health (MOH).

Continue reading “July 2018: Brazil Regulatory Updates”

June 2018: Brazil Regulatory Update

As stated in ResolutionNo9 and ResolutionNo222, applicants are responsible for paying a Proof of Deposit Health Surveillance Rate (TFVS) fee to submit a clinical trial application to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA).

Continue reading “June 2018: Brazil Regulatory Update”

May 2018: Brazil Regulatory Update

In accordance with the LawNo9.782ResolutionNo9, and Ord650/2014, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) is responsible for reviewing and approving clinical trial applications for registered and unregistered drugs. Continue reading “May 2018: Brazil Regulatory Update”

March 2018: Brazil Regulatory Updates

The country has a large number of treatment-naïve patients that are getting older and living longer, which affect the epidemiologic profile, increasing the prevalence of chronic diseases. Furthermore, the strong investigator-patient relationship increases the adherence and recruitment rates that rank them as top recruiters of trials they conduct. Continue reading “March 2018: Brazil Regulatory Updates”

February 2018: Brazil Regulatory Updates

In March 2017, the Brazilian Senate approved the PLS 200 law, after three years of debate. The law still needs approval from the Brazilian parliament before it can be implemented, but it aims to speed up the approvals process by removing bureaucracy from the analysis and registration of new drugs.13

PLS 200 optimises the regulatory framework and expedites regulatory approvals. It creates an accreditation process for research ethics committees under the national research ethics committee (CONEP), coordinated by the Secretariat for Science, Technology and Strategic Inputs (SCTIE), of the Brazilian Ministry of Health. It also creates a procedure for analysing study protocols for risk, standardising and setting deadlines. Protocols which have minimum-to-low risk can be fast-tracked, while medium-to-high risk protocols will proceed to the Ethics Committee approval process.14

The new law guarantees access to the experimental drug, post-study, if it proves to be beneficial and indispensable for the patient’s continued treatment after the end of the trial. It also contains provisions to protect the health of the patient by guaranteeing medical assistance by qualified personnel throughout the study.