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It has been over a year since China Food and Drug Administration (CFDA) announced Matters Concerning Bundling Review and Approval of Pharmaceutical Packaging Materials, Pharmaceutical Excipients and Drugs (Document No.134 [2016]). As a result, the China pharmaceutical packaging industry is experiencing a revolution.
Previously, packaging materials were reviewed independently from drugs in a registration system required by Regulations for the Control of Pharmaceutical Packaging Materials and Components in Direct Contact with Drugs (Directive 13 [2004]). For imported packaging materials, it is known as the imported pharmaceutical packaging material registration procedure. Under this procedure, packaging materials information and samples were submitted to CFDA, and if the submitted information and testing results were accepted by CFDA, the supplier was issued an Import Package Material for Drugs License, which enabled the use of the packaging material for domestic drug production and supply.
The principle of bundling review is that pharmaceutical companies should be responsible for drug quality and choosing suitable packaging materials; pharmaceutical packaging suppliers should be responsible for the quality of their products. According to bundling review, pharmaceutical companies will submit a drug application and then be issued an application number; the packaging suppliers are required to submit relevant supporting documents. It is a huge improvement in the drug product approval process, and brings China in line with regulated markets.
Bundling review brings more opportunities for cooperation between pharmaceutical and packaging companies – which will help improve drug quality and safety. West works closely with all customers to support their filings; for more on how West can support, contact a Technical Customer Support (TCS) representative.
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。
<br />In 2016, the China Federal Drug Administration (CFDA) made two announcements regarding packaging of parenteral drug products. Per these announcements, stability studies of packaging materials should refer to protection, compatibility, safety and functionality properties.
As China has become the fastest-growing market in generic drugs, China Food and Drug Administration (CFDA) is paying more attention to drug quality and setting a higher standard for pharmaceutical packaging. Compatibility of the drug with the packaging materials is one critical focus area.<br />
The Standing Committee of the National People’s Congress in China passed the revised Drug Administration Law (Revised Law) on 26-Aug-19. Effective 1-Dec-19, it is the first overhaul since 2001.The Revised Law addresses the major issues in the pharmaceutical industry, demonstrating the government’s efforts in strengthening supervision to ensure drug safety.
<p style="margin: 0in 0in 10pt;">The new regulation “Bundling Review and Approval of Packaging and Excipients with Drug Products” announced by the China Federal Drug Administration (CFDA) on August 10, 2016, has generated both interest and concern. While the CFDA has published several related guidelines in an effort to address questions, many still persist. </p>
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