The Center for Drug Evaluation (CDE) has released the “Innovative Chemical Drug Pre-Phase III Clinical Trial Meeting, Common Issues and Related Technical Requirements,” a document that takes immediate effect. This guidance aims to streamline the clinical development process by providing clarity on the common issues and general requirements of pre-Phase III communication meetings for innovative chemical drugs.
Enhancing Communication Between Drug Companies and CDE
The end of Phase II (EOP II)/pre-Phase III pharmaceutical communication meeting is a critical juncture in the dialogue between drug companies and the CDE. The newly released document outlines the objectives and expectations for these meetings, with the goal of enhancing the quality and efficiency of communication between applicants and drug evaluation institutions.
Adherence to International Standards
The guidance makes reference to ICH Q11 and other guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals (ICH). This alignment with international standards is intended to ensure that the development of innovative chemical drugs in China is in line with global best practices, facilitating a more cohesive approach to drug development and evaluation.-Fineline Info & Tech
