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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:
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
Several of West’s experts will be featured speakers at The Universe of Prefilled Syringes and Injection Devices organized by 2013 PDA Europe, which will be held November 5-6, 2013, in Basel, Switzerland. West’s representatives will report on the latest trends in the world of prefilled syringes and innovations in the field of self-injection devices.
As a caring corporate citizen, West has established a long-standing tradition of supporting the communities in which we work and live. Our comprehensive philanthropic efforts include three programs: 1) corporate giving through West, 2) the Herman O. West Foundation, a separate 501(c)(3) entity, and 3) our employee-led fundraising program, West without Borders.
<p><span>At West, </span><span>we are committed to advancing a culture of inclusion that values difference as a source of strength so that all employees may bring their whole selves to work. </span><span>We strive to create a workplace that is inclusive of all people, where team members feel respected and valued, and have the opportunity to excel. </span></p>
Philanthropy is a cornerstone of West's culture. It anchors our purpose of standing by the side of our customers to help make a difference in our global community.
The challenge of assuring integrity of a sterile package is more complicated than many realize. As such, drug formulators in pharmaceutical and biotechnology companies often times underestimate the potential impact of the primary packages they select. A critical aspect to understand is container closure integrity (CCI) and leakage (i.e., failure of CCI or package integrity), is a major quality issue for sterile injectable products, as shown below.
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