我国药物安全性评价及GLP的有效实施

我国新药在上市前,所进行的新药审批须经非临床与临床研究,其安全性评价尤为重要。新药非临床安全性研究的最终目的就是为了降低临床研究安全性方面的风险性,只有当GLP标准表明该药有充分的安全性和有效性,才可进入临床研究。由于我国医药行业存在诸多问题,多数新药临床前安全性评价不符合GLP标准,不得上市造福人类,药企也面临着无法生存的难题。因此,必须坚持和落实科学发展观,确保新药安全性评价以及GLP的有效实施。

China＇s Drug Safety Evaluation and the Effective Implementation of GLP

Now, in order to value the lives, new drugs must pass those two stages, which are non-cllnical and clinical studies before they are put on the market. The most important one is the safety study. The ultimate goal of the non-clinical drug safety study is to reduce the risks of testing the new drugs in the clinical study. And only if the GIP standards show the efficiency and safety of the dugs can they finally be allowed to use in the clinical studies. There are still many problems in China＇s pharmaceutical industry, and most of the pre-clinical drug safety evaluation is not up to the GLP standard. Thus, these new drugs can not benefit mankind, and the marketing of them will also cause the problems in the pharmaceutical enterprises.Therefore, we must implement the scientific concept of development to ensure the safety evaluation of new drugs, as well as the effective enforcement of the GLP.