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Since the Technical Guideline on Compatibility Study of Chemicals and Elastomeric Closures was published by the National Medical Products Administration (NMPA, previously known as CFDA) in April 2018, it is essential for pharmaceutical companies to perform compatibility studies. However, for some domestic pharmaceutical companies that lack experience, it is unclear how to perform such a study. To address this, a series of trainings was planned by China National Pharmaceutical Packaging Association (CNPPA) – with the first held in December 2018. There were over 100 attendees from pharmaceutical companies, pharmaceutical packaging companies, NMPA-affiliated labs, and the third-party labs. The training received positive feedback from the participants.
Ms. Huo Xiumin, formerly responsible for drug product review at CDE (Center for Drug Evaluation, NMPA), shared her understanding of Technical Guideline …. She highlighted that compatibility studies are the responsibility of pharmaceutical companies, and that they should work closely with packaging components suppliers. Ms. Lynn Yao, Scientific Affairs Manager at West, presented on the overseas regulatory landscape for extractables and leachables, focusing on regulatory requirements, safety risk assessments, general approaches and case studies. The other presenters comprised experts from domestic pharmaceutical packaging materials manufacturers, pharmaceutical companies, and government agencies.
The West Scientific Affairs and Technical Customer Support (TCS) teams constantly monitor the regulatory landscape worldwide, in order to help customers navigate the regulations and select components that meet the unique needs of their drug products. For more information, contact an Account Manager or TCS representative.
At West, our focus is on supporting the biopharmaceutical industry in qualification and commercialization of containment and delivery systems for injectable medicines. <span></span>Selecting high-quality drug packaging that meets regulatory standards is essential to a drug manufacturer’s success. <span></span>West’s top priority is delivering high-quality packaging products that meet the exacting quality standards and product specifications customers require.
West is committed to delivering safe and efficient drug packaging products to our customers. Part of that commitment involves keeping the industry abreast of the latest regulatory and technology developments/challenges in packaging and delivery. West recently hosted, at its Exton headquarters, an installment of the ongoing Educational Series, titled: <strong>Managing Risk in Injectable Drug Delivery: Regulatory and Technical Challenges and Solutions. <br /></strong><br />
In <a href="/zh-cn/blog/2017/june/packaging-supplier-regulatory-support-part-2">Part 2</a> of this series, we discussed the importance of choosing a packaging component supplier with a global focus. In this post, we’ll address the need for a supplier to understand and align with your drivers.
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。
It has been over a year since China Food and Drug Administration (CFDA) announced <em>Matters Concerning Bundling Review and Approval of Pharmaceutical Packaging Materials, Pharmaceutical Excipients and Drugs</em> (Document No.134 [2016]). As a result, the China pharmaceutical packaging industry is experiencing a revolution.
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