COURSE DESCRIPTION

OVERVIEW

In August 2019, the Revised Drug Administration Law (DAL) was published by the Chinese State Council (effective from Jan 2020) followed by the release of the new Drug Registration Regulation (DRR) in January 2020 (effective from Jul 2020). These two publications are milestones in the fundamental changes that have taken place in China since August 2015, with the initiation of deeper reform of drug development and approval polices. They provide the framework for all new drug development and drug registration in China. 

This session will introduce the official institutions governing drug development and registration in China and a detailed overview of the requirements laid out in the revised DAL and new DRR for the development of pharmaceutical products. Content will provide you with best practices for approaching the new regulatory environment, as well as critical points where the landscape has changed. Additionally, you will Learn from recent case studies on potential regulatory pathways leading to new imported and local drug registration in China.

LEARNING OBJECTIVES

At the completion of this session, you will be able to:

• Summarize the legal framework and government institutions involved in drug development and new drug registration in China
• Interpret requirements laid out in the DAL and DRR for conducting drug development in China 
• Identify requirements and process for registration of imported and local drug registration in China