Pharma Packaging & Labeling in China: 10 Compliance Points from the Detailed Rules

1. Drug packaging and labels must be produced strictly in line with the rules set by China's National Medical Products Administration (NMPA). No unapproved wording or graphics may be added. Drug packaging falls into inner and outer packaging. The information carried on packaging and labels may not go beyond what is defined in the NMPA-approved drug instructions.
2. Product descriptions on packaging and labels must be accurate and error-free. Except for language describing safe and rational drug use, no inappropriate promotional text or symbols may appear, including 'new drug', 'protected traditional Chinese medicine variety', 'GMP certification', 'sub-packaging of imported raw materials', 'supervised by', 'honorary product', 'award-winning product', 'quality insurance by an insurance company', 'reimbursable by public funds', 'modern technology', 'precious medicinal materials', and similar terms.
3. A drug's brand name may appear on packaging and labels only after NMPA approval. It must not be joined with the generic name and must be placed on a separate line. Even after trademark registration, the brand name must still follow brand-name management principles. The character area ratio of generic name to brand name must be at least 1:2. Generic names must use a uniform font size and must not be enclosed in parentheses. A registered trademark not approved by NMPA for use as a brand name may be printed in the upper-left or upper-right corner of the packaging label, with a font no larger than that of the generic name.
4. When the same company makes the same drug in identical specifications—covering both drug strength and pack size—the packaging and labels must share the same format and color, and different trademarks may not be used. If the same product from one company comes in multiple specifications, the smallest sales unit's packaging and labels must be clearly differentiated, or the specification must be prominently marked.
5. The smallest sales unit refers to the small pack supplied directly for a marketed drug. Every smallest sales unit must carry a label as required and be accompanied by instructions.
6. For specially controlled drugs such as narcotics, psychotropics, medicinal toxic drugs, and radioactive drugs, as well as external-use drugs and non-prescription drugs, compliant markings must appear on the large pack, medium pack, smallest sales unit, and label. Drugs with special storage requirements must state these requirements in a prominent position on the packaging and label.
7. Imported drug packaging and labels must follow these rules and also indicate the 'import drug registration certificate number' or 'pharmaceutical product registration certificate number', the manufacturer's name, and other required details. For imported drugs that are sub-packaged domestically, the packaging and labels must state the name of the enterprise in the original country or region, production date, batch number, expiry date, and the name of the domestic sub-packaging company.
8. For drugs approved for production in another location, packaging and labels must also show the group name, manufacturing enterprise, and production site. For drugs approved for contract manufacturing, packaging and labels must also show the names of both commissioning parties and the processing site.
9. For any drug sold and used in China, the text on packaging and labels must be mainly in Chinese and use the current standard characters issued by the State Language Commission. Ethnic medicines may add their ethnic script. Companies may use barcodes and foreign-language equivalents on drug packaging as needed. Products approved in China may also carry the mark and number and indicate the licensed category.
10. Expiry dates on packaging labels are expressed in year-month order. They may generally read as valid until a certain year and month, or use digits only—for example, valid until October 2001, or valid until 2001.10, 2001/10, 2001-10, and similar formats. The year must use four digits, and for January through September, a 0 must precede the number so the month is shown as two digits.

— Source: China Packaging Network (pack.cn), original link: http://news.pack.cn/show-362237.html