Registration of imported Generics in China
GRP’s presentation provides insights on the registration process of a generic imported drug in China, includes fees and timelines.
Clinical Trial Application (CTA) for Drugs in China
GRP’s presentation provides an overview on the CTA regulatory process, China CT platform, and CTA submission & review process in China.
NMPA Pre-approval Inspection in China
GRP’s presentation provides an overview on the Pre-approval inspection requirements, process, and timelines for drug submissions to CDE.
Post-Approval CMC Changes in China
GRP’s presentation provides an overview of the types of CMC changes and process in the post-approval stage in China.
Overview of China New GVP Requirements (Good Pharmacovigilance Practices)
GRP’s presentation provides an overview of the new Pharmacovigilance (GVP) requirements in China Released in December of 2021
Responsibilities of Local Agents in China
GRP’s presentation outlines important information regarding Local Representatives and their responsibilities in China.