我认为,生物制品的定义,还可以从药物注册的角度来看,“经发酵制备的具有生物活性的多组分制品”,而抗生素是单一组分制品,似乎不属于这个定义。
“未在国内外注册上市的生物制品”,还要看看国外怎么定义的。
Biological Product Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources — human, animal, or microorganism — and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.
很多多糖属于生物反应调节剂BRM,算不算生物制品?按照上述FDA的定义,似乎也算是生物制品,但是,药物注册的时候,走哪个程序呢?