Dilemma For Imported Drugs In China

In China, an imported drug may only be sold after an import registration certificate is granted by the Ministry of Public Health, but after this it is no longer eligible for protection against generic competition under the Regulations on Drug Administrative Protection. It is easier to register a new drug for sale, but administrative protection provides greater long-term benefits, according to China MediPharm Insights.

Drugs eligible for protection are those patented during 1986-1993 which have market authorizations in their applicant countries but which have not entered China. Products patented after 1993 are protected under the country's patent law.

One company falling foul of this dilemma is Amgen, which applied for Chinese registration of erythropoietin in 1992. This was approved in September, and Amgen subsequently gained the lion's share of the Chinese EPO market. Then the Regulations on Drug Administrative Protection took effect in 1993, and Amgen submitted an application for protection to the Office of Drug Administrative Protection on August 10, 1993. The Office initially accepted the application, but then rejected it because Amgen had already been selling EPO in China before submitting its application. Amgen's majority share of the huge EPO market in China was thus heavily reduced, as without administrative protection local producers could offer their own versions at much lower prices.