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以质量求生存、以品种求发展现已被愈来愈多的企业所接受。药厂为了生存,保证生产的药品质量是毋容置疑的。但本文主要是就药政管理方面谈谈药厂在开发新药中应注意的几个问题,以供大家参考。一、药品开发应该少剂型、多品种随着制药工业的发展,药品的新制剂也不断增加。我国药典53版时仅收载15种剂型,而到85版已达26种之多。由于各种剂型的工艺要求越来越高,所需的设备、检验仪器愈来愈先进,而根据《药品管理法》的规定,药政管理部门进行审批时就必须针对所报产品的剂型特点进行审批。当开发的药品是一个新剂型时,这种考察就更为详细而且显得非常必要。为了提高现有厂房、设备的利用率,减少开发药品的投资,缩短审批的
Survival by quality and development by variety have been accepted by more and more companies. To ensure the survival of pharmaceutical companies, the quality of drugs produced is unquestionable. However, this article mainly discusses several issues that pharmaceutical companies should pay attention to in the development of new drugs for the management of drug administration, for your reference. First, drug development should be less dosage type, more variety With the development of the pharmaceutical industry, new formulations of drugs are also increasing. At the time of the 53rd edition of the Chinese Pharmacopoeia, only 15 dosage forms were included, and as of the 85th edition, it has reached as many as 26 types. Due to the increasing process requirements for various dosage forms, the required equipment and inspection instruments are becoming more and more advanced. According to the “Drug Administration Law,” the drug administration department must examine the dosage form characteristics of the reported product when it is under examination and approval. For approval. When the drug being developed is a new formulation, this investigation is more detailed and necessary. In order to increase the utilization of existing plants and equipment, reduce investment in the development of pharmaceuticals and shorten the approval of