Case Study 31 : China Regulatory Intelligence for US Based Pharmaceutical Company

Company Situation

The Client is a biotech company based in USA that has active clinical trials in USA for multiple therapeutic areas. Client was exploring possibilities to register new drugs in China and wanted to understand comprehensive landscape for new drug registration, clinical trial and pharmacovigilance in China to enable executive management decision to venture in China.

GRP Solution

GRP has helped its Client’s successfully obtain New Drug Approvals in China using its iCRMAX platform – that is an integrated solution using regulatory, clinical, pharmacovigilance, market access and quality experience of global markets to enable faster time to market for new drugs. GRP, using’s experience provided the Client with a comprehensive regulatory intelligence landscape assessment of Chinese market for New Drug Registration and Safety requirements.

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China's NMPA

In China, the regulating Health Authority is  The National Medical Products Administration (NMPA) also formerly known as the China Food and Drug Administration or CFDA). The NMPA is a vice-ministerial-level administrative agency under the State Administration for Market Regulation (SAMR).