DRW Monthly
August 2008
Issue No. 21

Argentina Harmonizes Clinical Trial Regulatory Requirements to Conform with International Best Practices

Over the past several months, ANMAT ((National Administration for Food, Drugs and Technology) has introduced a number of rules governing clinical trials to more closely align Argentina's regulatory policies with current international best practices for clinical research. ANMAT is an independent body established in 1992 (Decree 1490/92) by the Ministry of Health to ensure the quality and safety of drugs, food and medical devices. The agency's responsibilities center on registering, monitoring and inspecting every healthcare product, both imported and locally produced, aimed at protecting and contributing to human health. ANMAT's Medicine Evaluation Direction Unit plays the primary role in evaluating clinical trials, registering and marketing drug products and protecting the rights of human subjects.

ANMAT began implementing a series of clinical research regulations in February 2008 with the issuance of Disposition 1067/2008: Amendment of Disposition 5330/97: New Text on Good Practices in Clinical Pharmacology Research. This amendment updates the country's fundamental guidelines for conducting clinical trials originally published in 1997 (Disposition 5330/97). It also repeals Disposition 2124/05 which addresses good clinical practices, security reports and adverse events in clinical pharmacological research. During the implementation of 2124/2005, it became clear to ANMAT authorities that the existing system needed to be optimized to ensure the proper reporting of clinical trial safety issues by sponsors and investigators. Consequently, Disposition 1067/2008 institutes a new form of reporting serious and unexpected adverse events. The revised reporting format improves both drug toxicity reporting on clinical studies within Argentina and provides more accurate data submissions to international drug research monitoring programs. The amended monitoring system now incorporates such international standards as the Pan American Network for Drug Regulatory Harmonization's Good Clinical Practices - Document of the Americas and the International Conference on Harmonisation efficacy guideline, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A).(1)

The agency's issuance of Disposition 1067/2008 was followed by its April 2008 publication of Circular No. 0003/08, Requirement for the Inclusion of an Explanatory Text in the Informed Consents for Patients. This letter requires the inclusion of explanatory text in the informed consent document to be signed by patients participating in clinical research. The text must point out 1) the experimental character of the research; 2) that it was authorized by ANMAT; and 3) ANMAT's free helpdesk number for those patients wishing to carry out any inquiry. In addition, effective April 2008, the text to be included in all experimental investigations must be written in capital red and framed in letter size Times New Roman - Type 11.(2)

Since July, ANMAT has introduced Disposition 06/08 on the Development of Procedures Relative to Clinical Pharmacological Trials that are Subject to the Approval of the ANMAT (July 2008). In this disposition, the National Bureau of Personal Data lays down procedures to be followed by all research institutions in order to obtain ANMAT approval prior to initiating clinical pharmacological research projects. ANMAT also released Disposition 4541/08 this month TO initiate the appointment of new members to its Clinical Trials Evaluator and Advisory Committee which was created by Disposition 1138/95.

Argentina has unquestionably made significant strides in strengthening its clinical trial regulations this year. Regulatory and medical experts in Latin American clinical research, however, continue to highlight the need to regulate ethical research committee activities as an essential part of the harmonization process.(3) The consensus is that the ethical aspects of clinical research remain greatly in need of improvement. Examples of incomplete ethical committee documentation, unreliable enforcement of subject protection, incomplete informed consents, and ethically or scientifically unjustified use of placebos are still numerous. Hopefully, the trend towards increased regulation will continue to diminish the disparities between Argentina's clinical research practices and those implemented according to internationally recognized good clinical practice standards.

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