China FDA publishes first report on self-inspection rule

Inspection Report for Drug Clinical Trial Data

On Jul. 22, 2015, CFDA issued the Announcement of Self-Examination and Inspection of Drug Clinical Trial Data (No.117, 2015). According to the requirement of “the most rigorous standard, the most strict supervision, the severe penalization and the most serious accountability and to safeguard the food and drug safety of the broad masses of the people, CFDA conducted drug clinical trial data inspections for the registration applications of the 1622 pending productions or imported drugs. The inspection work for drug clinical trial data was henceforth started and until now, a whole year has passed.

According to spirit of the State Council’s Comments on the reform of the review and approval system of medical devices for drugs (state issue 2015 No.44), to improve the transparency and impartiality of the inspection work for drug clinical trial data, implements the three openness principles of open standards, open procedures and open results, the Center for Food and Drug Inspection of CFDA carefully summarized the on-site inspection work for clinical trials of all the involving drugs in announcement No.117.

More details can be found in the link provided below:

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