The new Technical Note gathers a series of guidelines to sponsors, research centers and researchers involved in the conduct of clinical trials authorized by Anvisa and bioequivalence studies in order to enable the conduct of clinical trials in Brazil with the speed that the moment demands and ensuring the safety of participants.
Ongoing Clinical trials (Key Points):
- The adoption of alternative processes or modification to amendments of the clinical protocol made exclusively as a result of the Covid-19 countermeasures, no need Anvisa’s authorization.
- The Sponsor may choose to carry out visits by telemedicine, complying with the requirements defined in Ordinance No. 467 of March 20, 2020;
- The annual clinical trial report shall include information and justification on the need for changes or amendments to the protocol in light of actions to combat Covid-19 and any impacts of those changes/amendments on the integrity of the clinical trial. In addition, information should be provided about which and how trial participants were affected;
Initiating Pharmaceutical Clinical Trials for the Treatment or prevention of COVID-19:
- The requests for consent of clinical studies with drugs for prevention and treatment of COVID-19, on a priority basis, within an average period of 72 hours after the formal submission of the protocol.
- The Sponsor should give preference to using an electronic Case Report Form (CRF) to record all information required by the protocol.
Initiating Medical Device Clinical Trials for the Treatment or Prevention of COVID-19:
- RDC 375/2020 was published amending the clinical trial submission regime for the validation of medical devices of classes III and IV identified as priority for use in health services due to international public health emergency related to SARS-CoV-2.
Clinical Trial Application Content:
To submit clinical investigations regulated by RDC 375/2020, the following documentation must be petitioned and filed electronically:
- Completed clinical trial submission form
- Proof of payment or exemption from the Health Surveillance Fee (TFVS) (in place of that documentation may be submitted the technical information on the requirements for the performance of the device to combat COVID-19)
- Clinical trial protocol
- Proof that the clinical trial is registered in the International Clinical Trials Registration Plataform / World Health Organization (ICTRP/WHO) or others recognized bodies.
- Report of the Research Ethics Committee (CEP) issued to the first clinical trial site to submit the protocol for review by the CEP
- Submission of the final study report and notification of unexpected serious adverse events that have occurred in the national territory, the causality of which is possible, probable or established in relation to the product under investigation
Continuation or initiation of Bioequivalance Trials During COVID-19:
- For bioequivalence studies not yet started, it is suggested to postpone the first and other periods of admission of investigation subjects, in line with local contingency measures established by the authorities of health;
- For bioequivalence studies already begun in which one or more periods of hospitalization have not yet been performed, it is suggested that these periods be postponed. In this case, potential impacts should be described in the final reports of the study of that postponement.
About Global Regulatory Partners:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.
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