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The Law of Pharmaceutical Products, Medical devices and Sanitary products No. 29459, published in November, 2009, guides the regulations of these products, substituting Chapter III of the General Law of Health No. 26842. Through this law, the most questioned aspects of the Law No. 26842 have been modified, establishing requisites to apply for the sanitary registry of pharmaceutical products that are necessary to guarantee their efficacy, security and quality, also including the required terms for their evaluation and the cost of the health registration fee must be according to all what implies to give the registry, including control activities and health surveillance. It also resets the requirement of the operating health approval, prior to the initiation of the activities, and having had a previous inspection to verify the accomplishment of the actual legal devices. The law also incorporates three specific chapters about access, rational use of pharmaceutical products, medical devices and health products, as well as a chapter on research. [ABSTRACT FROM AUTHOR]

This review evaluates the relevant information on a variety of adverse drug reactions serious, real or potential, attributed to some drugs relatively recent introduction into the world market, in addition, on some intoxications by contaminated medicines, all of which contributed to decision-making in the past and present, by regulatory authorities in drugs in several countries. It explores the broad strategies related to the pillars of the drug policies, the historical and current events classified as disasters or tragedies in the use of drugs in the last century and this, in order to provide a basic picture in this process. We included health effects that affected by the use of some natural products to pay attention to its implications in medical practice. It says and discusses the decisions of international regulatory authorities, the strategies that have helped to avoid serious harm in society, by adverse reactions for innovative medicines and old. It contribute in strengthening the concepts of commercial and governmental responsibility, scientific, ethical and safety standards of drugs, the importance of quality control, bioethics, good clinical practice in the scientific research in drugs, good manufacturing practices and avoid corrupt practices. It reaffirms that the success of modern medicine is due to the sheer magnitude and drugs within them to innovators. Timely decisions are guided by experts to avoid tragedies, affliction and unnecessary expenses by adverse drug reactions. [ABSTRACT FROM AUTHOR]