On March 30, 2020, the revised Drug Registration Regulation was issued
by the State Administration for Marketing Regulation and will be put into
effect from July 1, 2020. The revised regulation is focused on the acceleration
of clinical trial approval, implementing a risk-based approach in clinical
development, protecting trial subjects’
rights, and overall enhancing the in-process administration, from filing,
review, and risk-based site inspections till suspension and even termination of
clinical trials. Also, we will touch on the liabilities throughout drug
lifecycle.
Encouragingly, the revised Drug Registration Regulation has optimized the overall review and approval framework, systems, principles, and procedures. It becomes another important milestone to foster the fast growth of the pharmaceutical industry and to further satisfy the unmet medical needs of the public in China.
This webinar is co-organised by Tigermed and SCCC.
Watch here the webinar recording: