China is aligning its regulatory environment with that of global standards with an aim to promote innovation, simplify drug development processes and to enhance the efficacy, quality and safety of the drugs approved. With the adoption of ICH guidelines for clinical safety and pharmacovigilance reporting by CFDA, traditional methods of managing adverse event data in excel sheets become redundant as they are non-compliant with the electronic standards defined by the ICH E2B (R3) guideline.
Download this whitepaper to learn how:
- LifeSphere Safety MultiVigilance (ARISc), the drug safety software application fully caters to the pharmacovigilance requirements of Chinese manufacturers
- LifeSphere Safety MultiVigilance supports compliance with electronic exchange of safety information both during clinical development and post-approval safety reporting in accordance with relevant ICH guidelines
- LifeSphere Electronic Submission module, allows electronic submission to various health authorities including CFDA