International regulatory uses of acute systemic toxicity data and integration of new approach methodologies.

Chemical regulatory authorities around the world require systemic toxicity data from acute exposures via the oral, dermal, and inhalation routes for human health risk assessment. To identify opportunities for regulatory uses of non-animal replacements for these tests, we reviewed acute systemic toxicity testing requirements for jurisdictions that participate in the International Cooperation on Alternative Test Methods (ICATM): Brazil, Canada, China, the European Union, Japan, South Korea, Taiwan, and the USA. The chemical sectors included in our review of each jurisdiction were cosmetics, consumer products, industrial chemicals, pharmaceuticals, medical devices, and pesticides. We found acute systemic toxicity data were most often required for hazard assessment, classification, and labeling, and to a lesser extent quantitative risk assessment. Where animal methods were required, animal reduction methods were typically recommended. For many jurisdictions and chemical sectors, non-animal alternatives are not accepted, but several jurisdictions provide guidance to support the use of test waivers to reduce animal use for specific applications. An understanding of international regulatory requirements for acute systemic toxicity testing will inform ICATM's strategy for the development, acceptance, and implementation of non-animal alternatives to assess the health hazards and risks associated with acute toxicity.

Brazilian Clinical Trials Registry and the challenges for clinical research governance.

Over the past five years, efforts to set up a Brazilian clinical trials registry have progressed from early discussions in academic forums through to the establishment of the registry as a web-based computer platform. This article describes the process of developing and introducing the Brazilian Clinical Trials Registry (ReBEC), and its relationship with the authorities that regulate clinical research in Brazil. The Brazilian Clinical Trials Registry and the multilingual, free and open source, internet-based software developed to manage it are outcomes of partnerships among Brazilian federal and international health agencies. Information for describing the technical and operational dimensions of Rebec was drawn from technical documents and the records of the OpenTrials software development team and the ReBEC executive and advisory committees, which are available in free-access repositories. The Brazilian Clinical Trials Registry was launched in December 2010, and approved as a primary registry of the WHO ICTRP network in April 2011. ReBEC's arrival on-line and its acceptance as an ICTRP primary registry is a significant step in consolidating a policy of free access to information on clinical research in Brazil.