New Labeling Requirements for Pharmaceuticals in Taiwan

In an effort to prevent and reduce errors in administering medication, Taiwan’s Legislative Yuan (Council) ratified a revision of the Pharmacy Law on January, 14, 2003, requiring that all medicines sold in Taiwan must have labels in Chinese. Due to increased instances of patients being given incorrect medication, manufacturers as well as importers who have not yet entered the market will be required to add Chinese labels to their drug products before they are placed in the market. For manufacturers and importers who already sell and distribute within the Taiwanese market, they will be given a grace period of three months to comply. The new regulation also holds true for products that are manufactured and packaged locally in Taiwan that are sold locally as well as internationally.

In addition to the original requirements, the new regulation mandates that information about a drug’s contents, functions, specifications, and main manufacturing methods must be labeled in Chinese. The labels should be submitted to the Department of Health (DOH) for registration and approval prior to the product’s market introduction. The DOH is the government agency responsible for reviewing the new labels.

Any pharmaceutical company who fails to comply with the new legislation will be fined between NT$60,000 (US$1,730) and NT$300,000 (US$8,630). Failure to add the correct labels after the first fine, will subsequently lead to heavier fines.

There are concerns, however, that the new law will have loopholes. Due to “practical difficulties,” health officials are able to make exceptions to the labeling law. This allows more opportunities for bribery to occur between importers and health officials in Taiwan. The DOH, however, continues to stress their determination to enforce the new regulation for Chinese labels.