化学药品特殊注射剂仿制药药学研究技术要求

CMC requirements for complex generic injections

特殊注射剂通常为改良型药物,通过对剂型、处方、工艺等进行优化设计解决药物的先天不足,以降低药物不良反应、提高疗效、提升患者顺应性等,具有较高的临床价值。特殊注射剂通常具有复杂的处方或采用特殊的制备工艺,具有较高的技术壁垒,在竞争日益激烈的仿制药市场中具有较大的优势。本文参考国内外指导原则,结合特殊注射剂的制剂特点,简要探讨化学药品特殊注射剂仿制药开发过程中药学研究需要关注的内容和技术要求。

Complex injections are usually a kind of modified new drugs with new dosage forms,formulations and manufacture processes.It is an effective method to reduce inherent deficiencies of active ingredients with advanced techniques.Complex injections can reduce side effects of drug substances,improve drug efficacy,promote patients’compliance and so on.In the increasingly competitive generic drug market,they have obvious clinical advantages and market competitiveness.However,complex injections usually own complicated formulations and processes.Based on guidances and policies at home and abroad,in this paper,we briefly discussed the CMC requirements for complex generic injections according to the characteristics of different complex injections.