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OBJECTIVE:To provide reference for drug registration declaration. METHODS:The disapproval comments of Chi-na Food and Drug Administration on the declared drugs in Guangdong Province in 2015 were collected,existing problems in cur-rent drug registration declaration in clinical trials stage and registered production stage were analyzed. And suggestions were put for-ward based on relevant policies and regulations. RESULTS & CONCLUSIONS:Reasons for the rejection of declaring chemical drugs in clinical trials stage mainly focused on that there had been imported drugs applied for registration or new drugs entering monitoring period. While pharmacy research quality defects,especially insufficient research in impurities and relevant materials, are the main problems of declaring clinical trials and production. In terms of clinical trail declaration,applicant should respond to new drug registration classification reform,strengthen original innovation development;the development of biological products should establish comprehensive and effective evaluation system to form superior technology and products. In terms of drug registra-tion production declaration,related departments or drug manufacturers should enhance the evaluation for drug form and specifica-tions design,and generic drugs should pay attention to the consistency evaluation with the original research drugs. Besides,the above problems can be solved by conducting scientific and feasible research methods for impurities and related material,and pay at-tention to enlarging research of forward-looking production technology.
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OBJECTIVE:To review the recent advances in analgesics study and summarize the drugs for central sensitization and analgesia model by relating to the latest means and methods of research.DATA SOURCES:The literature on analgesics was retrieved in NCBI database for the related papers published between January 1996 and December 2001, with the key words of "analgesia", "analgesic", and "pain"and language restricted to English. At the same time, papers published in the past two years were retrieved in http:∥www.wanfangdata.com.cn, with the key words of "analgesia", "analgesic" and "ganglioplegic" in Chinese and the language restricted to Chinese.STUDY SELECTION:Totally more than 50 000 research references repeated contents.DATA EXTRACTION: Altogether 100 basic research articles were collected. We selected 15 articles relevant to the research development in analgesic drugs, and excluded 82 review papers with repeated content.expressed by proto-oncogene c-Fos located in the nucleus is a kind of DNA conjugated protein. It can regulate the expression of some pain-related genes. Some studies found that substance P synthesis is likely to play a research: Developing the central sensitization drugs is the orientation of sal root ganglion neurons and model of swallowing response were established.CONCLUSION:By investigating the effects of various new research methods and models on pain, we intended to look for more new drugs, to further study neurotransmitters and the clone of transmitter receptor at the cellular and molecular level so as to find the new effect target of the drugs, and to have a better understanding of the integrity of chronic pain in humans and achieve more breakthroughs in the development of neuroscience research.