Regulatory issues clinical trial safety

Where you stand [on an issue] depends on where you sit is an old truism of public administration. It is essential, therefore, to clarify at the outset the perspective we bring to this examination of DoD-FDA interactions. The literature on commercial drug development emphasizes the complexity and uncertainty of research and development, especially clinical trials, and the FDA regulatory requirements for safety and effectiveness that a new drug must meet before... 

The regulatory authority in Mexico is the Direccion General de Control de Insumos para la Salud (DIGE-CIS). The Health Secretariat issues pharmaceutical registration. Safety and efficacy must be proven by phase III clinical trials in Mexico to register drugs that are new to the Mexican market. All major pharmacopeia (/ntemahona/ Pharmacopoeia, US Pharmacopeia, British Pharmacopoeia, French Pharmacopoeia, Swiss Pharmacopoeia, European Pharmacopoeia, and Japanese Pharmacopoeia) are acceptable in Mexico. 

ICH. International Conference on Harmonisation. An international forum for regulatory authorities in the European Union, Japan and the United States established in 1990. The ICH has issued more than 60 documents of regulatory guidance divided into the major areas of Quality (Q), Safety (S), Efficacy (E) and Multidisciplinary (M). Many of these are relevant to this book but the most relevant is ICH E9 Statistical Principles for Clinical Trials. 

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