Clinical technical requirements for overseas listed drugs

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In: Inspection/Test, Medicine/medical devices, NMPA
On October 12, the center of drug evaluation (CDE) of the National medical product Administration issued the clinical technical requirements for overseas listed but domestic unlisted drugs, involving original research chemicals and therapeutic biological products that have been listed abroad, and generic chemical drugs at home and abroad. The technical requirements of clinical trials should fully evaluate the clinical needs of Chinese patients, the clinical safety and effectiveness of overseas original drugs, and the influence of race and other factors. Clinical needs assessmentEffectiveness and safety evaluationRace sensitivity analysisBenefit / risk assessment of Chinese patients The technical requirements also list theRead More →

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