China: New Classification Categories for Chemical, Biologic Pharmaceuticals

Chemical and biologic drugs are required to be classified into new categories for registration in China under new guidance issued by the Center for Drug Evaluation of National Medical Products Administration


Under the new classification system, which went into effect on July 1, chemical drugs must be classified as either innovative, generic, previously marketed overseas, or improved drugs. Biological pharmaceuticals must be classified as preventative, therapeutic, or as IVD reagents.