The scale of the current market demand for pharmaceutical aluminum tubes in China in 2020 is ever-expanding. Of the dozens of manufacturers specializing in pharmaceutical-grade aluminum tubes, only a few are registered with the Drug Administration because China previously presided over the National Drug Administration. Manufacturers of drug packaging certificates issued by the Bureau have a validity period of at least 5 years. The drug packaging certificates began gradually expiring in January 2018, which has necessitated suppliers to comply with the new, more stringent regulations. China Food and Drug Administration (CFDA) implemented a related review management system in January 2018, which endorsed the following principal changes:
- Exploring the establishment of a system of review and approval of medicinal excipients, packaging materials, and drugs with the focus on quality risk control as the core and record management as the means.
- Reclarifing the primary responsibilities of pharmaceutical manufacturers to supervise and fulfil the audit duties of suppliers.
- Promoting and extending the monitoring of pharmaceutical excipients and pharmaceutical packaging material manufacturers.
- Implementing the organized management of medicinal excipients and pharmaceutical packaging materials according to the degree of risk to attain increased better control.
- Improving the Standards System by taking a page from the DMF-Drug Master File in the United States, which delegates the responsibility for the supervision of pharmaceutical packaging materials suppliers to the supply chain management responsible for pharmaceutical factories, and cancels the permit system now in place that is directly administered by the Chinese government.
Packaging manufacturers are now obliged to offer such an extensive array of specifications and standards to their potential customers, pharmaceutical companies themselves are in a dominant position when it comes to the question of overall quality. This aspect helps keep the production of inferior products in the marketplace to a minimum. It therein strengthens the open market, which in turn requires both pharmaceutical companies and suppliers alike to invest in additional human and material resources to help grow the industry. The intention of this approach to bring China’s current management system of drug-related industries more in line with accepted international standards.
Author
Nick Jacobs is a marketing and content specialist at Xinrontube with a primary focus on Marketing and Business Development. Being a true humanist, he draws inspiration from the simple things as everyday life and the matters one come across on a daily basis doing his best and above to help everyone around.
