BRIEF—China issues clinical guidance for CNS drugs

China has issued a clinical study guideline for bipolar disorder and schizophrenia drugs.

According to the National Medical Products Administration (NMPA, formerly CFDA), the guidance, which is not mandatory, borrowed knowledge from the European Medicines Agency and the US Food and Drug Administration, aims to improve China's clinical trial quality for novel drug candidates developed in the country.

While cancers are the hot target for many Chinese pharmas, some are targeting mental diseases.

Luye Pharma, for example, in September received an investigational new drug (IND) approval from the FDA for LY03010, a schizophrenia treatment.