China Issues Notice on New Drug Nomenclature Guidelines

China’s State Food and Drug Administration (SFDA) recently issued a notice on new Drug Nomenclature Guidelines to begin standardizing drug names. In the past, many imitation drugs were registered under the unique brand or trade name, which created confusion in the marketplace. According to the notice, only new chemical compounds, new active ingredients, and patented chemical compound drugs may use brand names; all other categories must use the drug’s common or adopted name. The brand name must follow strictly the Drug Nomenclature Guidelines, and common name of the drug must be clearly displayed on all drug packaging.

The Guidelines stipulate that the brand name cannot exaggerate the therapeutic nature of the drug or be directly indicative of the drug’s ingredients or function. It also cannot sound like the drug’s common name, or be identical or similar to other manufacturers’ names. Furthermore, the brand name also cannot use any language prohibited by the China Trademark Regulations.

Use of the brand name must first be approved by the SFDA, and must also adhere strictly to the Provisions for Drug Registration. Manufacturers producing drugs with the same active ingredient (but in different dosages) should use the same brand name for both drugs. Brand names will not be permitted to be used independently in any drug advertisements.

From June 1, 2006, all names and trademarks for newly registered drugs must also comply with the new Drug Insert & Label Regulations issued in March 2006, which forbids drug manufacturers from using unregistered trademarks or drug names not yet approved by the SFDA on any drug inserts or labels.