Clinical Investigations
This article was originally published in RAJ Devices
Executive Summary
Brazil implements more stringent requirements for sponsors
Brazil implements more stringent requirements for sponsors
A resolution issued by the Brazilian National Health Monitoring Agency, Anvisa, sets out new, more stringent requirements for sponsors and research centres wishing to conduct clinical investigations of pharmaceuticals and healthcare products in Brazil1,2. The new regulation requires sponsors to submit more detailed dossiers for review before the clinical trial can receive approval, or a Comunicado Especial, by Gepec (Gerência de Medicamentos Novos, Pesquisas e Ensaios Clinicos), Anvisa's office for the management of new medicines, research and clinical trials. In addition, the resolution, issued in September 2004, incorporates international good clinical practice (GCP) standards, holding clinical investigators to more rigorous requirements.
These changes have been made in order to ensure a higher level of data consistency and reduce the risk to trial participants. In addition, the resolution is intended to provide a level playing field for Brazilian companies wishing to compete with multinationals in the area of clinical research.
Among other documentation, the dossiers must now include:
- the study protocol;
- detailed information about the sponsor and research centre/institution that will carry out the investigation;
- declaration by the sponsor assuming responsibility for any product-related adverse events;
- details of the study's estimated budget, specifying hospital expenses, visits with other health professionals, materials, etc;
- evidence that the ethics committee within the research centre where the study will be carried out is registered with the National Commission on Ethics in Research (Comissão Nacional de Ética em Pesquisa - Conep);
- proof that the research centre's ethics committee has approved the study;
- registration information for the product in Brazil and, if applicable, in other countries;
- details of research carried out on the drug or healthcare product in other countries;
- for products in Phase I, II and III of investigation, the Brochura do Investigador (ie a compilation of all clinical and nonclinical data relating to the product under investigation that are relevant to human studies) and the package insert;
- for products in Phase IV, information concerning the product that has been obtained from the prior phases of research (ie preclinical results, with emphasis on safety and toxicity data, adverse reactions and product efficacy information); and
- an estimate of the quantity of medicines or products that will need to be imported into the country in order to carry out the study, if possible.
Anvisa/Gepec has the authority to request additional information from the sponsor at any time during its review of the dossier, and if it deems necessary, to suggest alterations to the study protocol. Once the study is underway, Anvisa/Gepec may also request further information and may temporarily suspend or cancel the study if it has cause for concern.
References
1. Anvisa press release, 14 October 2004, www.anvisa.gov.br
2. Resolução RDC No 219, 20 September 2004, www.anvisa.gov.br