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).