药物一致性评价实施与药用辅料关联审评的探讨

Study on the relationship between drug re-evaluation and pharmaceutical excipients

目前国产药品95%以上都是仿制药,但这些仿制的原料药生产并不比发达国家落后,而是制成制剂后这些药品中的大部分无论从质量及临床疗效与对照品相比差距颇大,其重要原因之一即在于国产药用辅料品种开发上的落后。为了使患者能用上放心药,国家政府部门对仿制药的质量提升设置了时间节点,国内仿制药质量一致性评价工作的深入推进也给药用辅料提出了更高要求,这些势必会带动医药工业提高对原辅料的品质要求,势必规范辅料行业整体的质量控制与流程管理。没有好的药用辅料就没有好的制剂也不会有好的药品,而没有好的药品要想完成一致性评价以及走出国门融入国际市场也只是一种奢望,要想从用药大国走向制药强国更是一种空想,所以时下对于国内药用辅料行业发展的研究也成为业内外的聚焦点。

Nowadays, more than 95% domestic drugs are generic drugs. The quality of APIs in these generic drugs is not worse than those in developed countries. However, after preparations are manufactured, there is a huge gap between most of domestic producing drugs and reference substances in terms of quality and clinical efficacy. One of the important reasons is that the development of domestic pharmaceutical excipients falls behind. To ensure the drug safety of the public, the government has set deadline for the quality improvement of generic drugs. The deepening of quality re-evaluation of domestic generic drugs also raises higher demands for pharmaceutical excipients. It leads pharmaceutical industry to increase standard for the quality of raw materials, and to standardize the quality control and process management in excipient industry. There would be no good drugs and good preparations if there are no good excipients. It is a fantasy that we can pass quality re-evaluation and get into international market without good drugs. It is also a pipe dream to become a powerful country in pharmaceutical production without good drugs. Therefore, both inside and outside of the industry have been currently focus on the study of the development of domestic pharmaceutical excipients.