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药品是人民群众与疾病作斗争的有力武器,药品的质量直接关系到人民群众生命健康。它是防病治病,保护人们健康的特殊商品,随着医药科研的发展,许多新药品种不断上市,如何选择好质量优、能满足临床需要的新药品,是药剂管理中的一个新课题,对此,笔者认为有以下几点:1.首先加强新药品种品牌的审批管理 加强药品品种品牌的审批工作是保证新药品种质量的首要关口,必须严格、科学的审批,有关部门不能擅自扩大审批范围,要严格新开办药品生产企业的审批,对未取得药品GMP认证证书的不得发给《药品生产企业许可证》,对进口药品要查对有无进口药品注册证及有效性,还要查看口岸药检所的检验报告书,新药必须要有合法的手续和科学依据。
Medicine is a powerful weapon for the people to fight the disease. The quality of medicines directly affects people’s lives and health. It is a special commodity for prevention and treatment of diseases and protection of people’s health. With the development of medical research, many new drug products are listed on the market. How to choose new medicines with good quality and meet clinical needs is a new issue in pharmaceutical management. In this regard, I think the following points: 1. First of all, to strengthen the approval of new drug brand management to strengthen drug product brand approval is to ensure the quality of new drug varieties of the primary gateway must be strict and scientific approval, the relevant departments can not arbitrarily expand the scope of approval , We must strictly start the examination and approval of drug manufacturing enterprises, and may not issue the “Drug Production Enterprise License” without obtaining the GMP certificate of medicine. Check the import and export license for the imported medicine and the validity of the imported drug certificate, and also check the port Drug test reports, new drugs must have legal formalities and scientific basis.