Dear Relevant Departments, Since April 29, 2000, the "Administrative Measures for Materials and Containers for Pharmaceutical Packaging" (Provisional) (Decree No. 21) has been in effect, marking the introduction of a product registration system for pharmaceutical packaging materials in China. Over the past six years, most products have moved into the re-registration phase. During this time, regulatory changes and the process of registration and approval have led to significant adjustments in the classification and data requirements for registered products. Additionally, new requirements regarding direct-contact pharmaceutical packaging materials have been incorporated into drug registration management procedures. To date, there are 139 standards (YBB) for packaging materials and containers that come into direct contact with pharmaceuticals, developed by the State Food and Drug Administration. Some of these standards have undergone revisions. Since 2005, association standards for pharmaceutical packaging materials have also been established, including those for glass products. As the standardization system for pharmaceutical packaging continues to improve, China’s pharmaceutical packaging industry has gradually transitioned onto a legal track. This has increased the attention from pharmaceutical companies on the development and adherence to packaging material standards. In an effort to enhance understanding among enterprises about the regulations and standards governing pharmaceutical packaging, the China Pharmaceutical Packaging Association will organize a seminar titled “Pharmaceutical Packaging Management and Standardization Development†during the 57th China International API / Intermediates / Packaging / Equipment Autumn Fair, which will take place from November 15 to 17, 2006. The seminar will be held on November 16, 2006, from 9:30 a.m. to 12:00 p.m., in Room 5501, Hall 5, Qingdao International Convention and Exhibition Center (No. 9 Miaoling Road, Century Plaza, Qingdao High-tech Zone). The seminar will feature expert presentations and discussions on key topics such as China's pharmaceutical packaging regulations, current industry status, and the registration process for packaging materials. It is hoped that technical leaders from pharmaceutical packaging and production companies will attend. Key details of the event are as follows: I. Date and Time: November 16, 2006, 9:30 a.m. – 12:00 p.m. II. Venue: Room 5501, Hall 5, Qingdao International Convention and Exhibition Center III. Topics: - China’s pharmaceutical packaging regulations and industry status - Overview of direct-contact pharmaceutical packaging materials IV. Fee: 100 RMB per person V. Registration: Please return the registration form to the Association Secretariat before November 10. Participants may also transfer fees to the Association account or make early payments. The Secretariat will issue invoices and badges either in advance or on-site, and note the payment date accordingly. Please refer to the attached documents for bank transfer and postal remittance information. October 8, 2006
Annex I: Bank Transfer and Remittance Information
Bank Account Name: China Pharmaceutical Packaging Association Bank: China Construction Bank, Exhibition Road Branch Account Number: 6510003042610002989 Postal Remittance Address: Room 501, Wenhuiyuan South Road, Haidian District, Beijing (China Medical News) Postal Code: 100088 Phone: 62267180, 62262760 Fax: 010—62267098
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