中国化学药品注射剂仿制药质量和疗效一致性评价

随着医药科技不断发展和进步，中国的药品审评标准在不断改变和提高，过去的药品审评标准没有强制要求仿制药与原研药质量和疗效一致，所以有些药品在质量、疗效上与原研药存在一定差距，需要改进提高。自2015年开始，国家药品监督管理局（原国家食品药品监督管理总局）推出仿制药质量和疗效一致性评价，借以提高我国仿制药的质量和疗效。质量和疗效视为等同于原研产品的仿制药将在公立医院的招标和处方中享受优先待遇。

To implement the GQEC policy, in 2017, NMPA Center for Drug Evaluation (CDE) published The Technical Requirements for Consistency in Evaluation of Marketed Generic Chemical Drugs (Injections) (Exposure Draft)¹. This document is used for the re-evaluation of generics which have not been reviewed and approved in accordance with the principle of consistent quality and efficacy.

On October 15, 2019, NMPA issued The Technical Requirements for Consistency in Evaluation of Quality and Efficacy of Generic Chemical Injections (Exposure Draft)². This is applicable to all generic drugs, marking the full launch of consistency evaluation in China. This draft clarifies the requirements on the reference preparation, drug formulation, quality control of API, excipients and packaging materials, study of drug quality and control, as well as stability study.

The consistency evaluation stipulates the following requirements on packaging materials:

1. The primary packaging materials should meet the pharmaceutical packaging materials standards issued by the NMPA or relevant requirements in USP, Ph. Eur, or JP.
2. The depyrogenation validation for primary packaging materials should be performed, or alternatively, its relevant certification issued by supplier.
3. The packaging system shall be verified for container closure integrity; physical analysis techniques could be used when the test method shall be properly validated.
4. Compatibility studies should be carried out in accordance with the relevant guidelines published by CDE.
5. The quality and performance of the packaging materials used for the injection shall not be inferior to that of the reference preparation
6. According to ICH Q3D, the control strategy for element impurities is developed through scientific and risk-based assessment, including elemental impurities leached from the packaging materials.

These requirements encourage pharmaceutical companies to conduct more comprehensive study on packaging materials, production process, and drug products, so as to ensure that the quality and efficacy of generic drugs are consistent with that of innovator drugs, and ultimately to assure the safety of drugs intended for use by the public. The West Scientific Affairs team will continue to focus on monitoring and understanding the dynamic regulatory landscape and help customers navigate these changes.

In addition, West is introducing a new product in April in China, which would support customers in the generics space in meeting the stringent requirements of GQCE. To learn more, kindly contact an Account Manager or the Technical Customer Support team