Experimental Cancer Drugs Need Fda Issued Technical Guidelines
According to ” Drugs Registration “, for the guidance of drug research and development, the state Food Drug Administration formulated the “Drug Cancer Test the principle of the need for technical guidance, “and was recently issued. The “guiding principles” elaborated the circumstances under which the need for experimental cancer drugs to prevent experimental animal resources, human resources and the unnecessary use of material resources; apply to “Drug Registration” in the relevant chemical drugs, the basic principle also applies to Traditional Chinese medicine , Natural medicines and biological products.
Cancer drugs on the issuance of the need for the technology trial to inform the guiding principles State Food and Drug Administration
Note [2010] 129
Provinces, autonomous regions and municipalities directly under Food and Drug Administration (Drug Administration):
Under the “Measures for the Administration of Drug Registration”, for the guidance of drug research and development, the State Council formulated the “experimental cancer drugs need technical guidelines”, are to be issued, please refer to the Executive.
State Food and Drug Administration
Experimental cancer drugs need
technical guidelines
1. Foreword
Cancer trials are designed to study potential drugs in animal carcinogenicity to evaluate and predict the possible harm to human body. Any in vitro, animal toxicity and potential human application of emerging factors in cancer may prompt the need for carcinogenicity testing. Internationally, the expected long-term use of drugs has been called for rodent carcinogenicity tests. In the study the potential carcinogenic effects of drugs, the cancer-causing genetic toxicity tests and over the existing system more meaningful exposure assessment techniques. These tests also help to understand the genetic toxicity of drugs without the potential carcinogenic effects. Now routine for pre-clinical safety evaluation of genetic toxicity tests, toxicokinetics and toxicity mechanism of experimental data, not only to help determine the need for carcinogenicity testing, but for the interpretation of results and the relevance of human security is also very important. As the cancer tests of time-consuming and animal resources, only when really need long-term administration of animal drugs in evaluation of human exposure to potentially carcinogenic due only when cancer tests should be carried out.
2. Historical background
In Japan, according to the 1990 “Guiding Principles of Drug Toxicity Handbook”, if the clinical expectations of atorvastatin for 6 months or longer, the need for carcinogenicity testing. Despite continuous medication less than 6 months, if there is a potential carcinogenic factors may need to test for cancer. In the United States, most widely used drug in the body before the animal carcinogenicity tests have been conducted. According to the U.S. Food and Drug Administration (FDA) requirements, general drug use 3 months or longer, the need for carcinogenicity testing. In Europe, “European Economic Community Drugs Act” provides for the need for carcinogenicity testing, including long-term application of drugs, that is at least 6 months of continuous medication, or frequent intermittent so that the total drug exposure similar to the former drugs.
Since 2005, China’s “Drug Registration” provisions of the annex is expected to clinical medicine for 6 months or more continuous or intermittent use of drugs often need to conduct carcinogenicity testing should be, and pointed out to cancer trial a number of considerations . January 2007 the State Food and Drug Administration Center for Drug Evaluation, “issued by the treatment with non-clinical safety of biological products, technical review of the general principles” elaborated cancer testing requirements related products.
2009 10 Center for Drug Evaluation, Organization of toxicological experts, representatives of enterprises and research institutions convened to develop “drug carcinogenicity tests need technical guidelines” symposium, at which the basic recognition of the applicability of the contents ICHS1A , combined with some adjustments to the domestic situation.
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