An update on the regulatory status of PDT photosensitizers in China.
Numerous photosensitizers have been developed and evaluated in China. HiPorfin, a hematoporphyrin derivative (HpD) received the first regulatory approval in the early 2000s. Aila, a topical formulation containing predrug 5-aminolevulinic acid, received the regulatory approval in 2007. Recently, new drug applications have been filed for several hematoporphyrin derivatives and a zinc phthalocyanine (ZnPc) derivative. This short report will summarize the current regulatory status of Chinese photosensitizers developed for photodynamic therapy (PDT).
Department of Radiation Oncology, University of Colorado Denver, Aurora, CO 80045, USA. zheng huang@msn.com
Zheng
Z
Huang
D002681:China; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D010778:Photochemotherapy / Q000592:standards*; D017319:Photosensitizing Agents / Q000592:standards*
D017319:Photosensitizing Agents