(Yicai Global) July 11 -- China’s drug regulators will allow companies to use overseas clinical trial data in their applications for new drug approvals as part of efforts to accelerate the introduction of new medicines in the country.
China Food and Drug Administration has released a new guiding principle paper to reveal more details for the move, which was first proposed last October.
Due to the globalized nature of drug research and development, more and more multinationals and Chinese firms use international multi-center clinical trials to support their registration application.
Companies looking to use overseas clinical trial data in their application will need to ensure results are authentic, accurate and traceable, the document states. The data generation process should also conform to the relevant requirements of the Good Clinical Practice of the International Council for Harmonization.
The applicants must also ensure that overseas trials are designed in a scientific manner, the quality control standard of clinical trials meets relevant requirements, and the statistical analysis of data is correct and complete. Companies will no be allowed to use the international data selectively and must disclose all data conducted for the clinical trials.
Editor: William Clegg