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为了在平时和战时保障广大指战员的生命和健康,军内需要研制一些具有军事应用目的的新药.军队内研究新药,同样要保证安全和有效,要保证药物的质量标准.因此军内新药研究,同样要执行国家卫生部颁发的(82)卫药字第15号文件《新药管理办法》(修订稿)》的有关规定.在这一文件中,卫生部从药政管理的要求出发对新药作了分类(附件一),提出了各类新药申请临床试验时需要报送的资料(附件二),同时还规定了新药申请生产时需要报送的资料(附件三).这些规定同样适用于军内,同样是军内新药研究应该遵守的法规.
In order to protect the lives and health of a large number of officers and soldiers at ordinary times and during wartime, some new drugs for military applications need to be developed within the military. To study new drugs in the armed forces must also ensure the safety and effectiveness and ensure the quality standards of the drugs. Therefore, , The same shall be implemented by the State Ministry of Health (82) Weiyao Zi No. 15 “New Drug Administration Measures” (revised draft) "in the relevant provisions of this document, the Ministry of Health from the requirements of the administration of medicine on the new drug (Appendix 1), put forward the need to submit all kinds of new drug clinical trial data submitted (Annex II), also provides for the new drug application for submission of information (Annex III) These provisions also apply to Within the military, the same is the law that military drug research should follow.