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).
Huang
Zheng
Z
Department of Radiation Oncology, University of Colorado Denver, Aurora, CO 80045, USA. zheng huang@msn.com
D002681:China; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D010778:Photochemotherapy / Q000592:standards*; D017319:Photosensitizing Agents / Q000592:standards*
D017319:Photosensitizing Agents