Regulation and Development

The establishment of medicinal regulatory agency’s intent is in facilitating and protecting public health interest by ensuring the safety and efficacy evaluation of medicinal products (biologics, devices, drugs) and other pharmaceutical components distributed or marketed for public use. In much respect, public opinion is necessary in regulatory issues, but in some cases, its contents are derivatives of assumptions and not based on scientific or evidence-based research. In the absence of coercion, incompetence and malpractice, the public should be able to confide and trust the regulatory agencies. At the same level of trust and confidence, the regulatory agency should be able to demonstrate and establish a high level of integrity by maintaining a transparent and unbiased regulatory pattern. The regulatory agency’s review advisory committee, regulatory personnel, etc. makes the most important decision concerning public health in terms of the safety and efficacy of investigational medicinal products or other products. These decisions

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