The Breakthrough Therapy Designation (BTD) pathway has been developed by the National Medical Products Administration (NMPA) of China.

This pathway can be used where Breakthrough Therapy designation helps to accelerate the review of drugs that treat serious conditions and have early clinical evidence to suggest that the drug may demonstrate a substantial improvement over currently available therapies. Applicants should base their decisions based on the product’s characteristics, number of clinical trial subjects, efficacy standards, whether there is clinical research data generated in China, combination drugs, etc. A BTD application strategy may be different for drugs first in class or drugs with mature targets. For drugs not used in the treatment of rare diseases and cancer, it is even more necessary to provide ample detail about the treatment advantages of their products to convince the regulatory agency of the drug’s true clinical value. Being one of the key parties in the development and implementation of R&D strategies, the drug registration team should be highly aware of China’s constantly evolving regulatory policies and be able to identify opportunities. They should devise strategies from clinical development to the application of marketing authorization and execute them cautiously and scientifically. When necessary, they should also coordinate internal resources and establish a detailed process from application to review and then finally to approval. Moreover, timing of submissions is critical — generally, no later than phase III clinical trials. Rejected applications are often the result of premature submission, insufficient data, or a failure to prove significant clinical advantages. .

CDE response within 45 working days; Publicity for 5 working days before official grant. CDE also prioritize resource for communication (Type I meeting , 30 working days) and provide intensive guidance on development.